Monitoring and management of physiologic parameters of a subject

ABSTRACT

A method includes receiving monitoring data from at least one sensing device coupled to a subject and analyzing the monitoring data to identify one or more physiologic parameters of the subject. The method also includes providing signaling to at least one stimulating device in response to the identified physiologic parameters, the signaling comprising instructions to apply a stimulus to the subject. The method further includes receiving additional monitoring data from the at least one sensing device, analyzing the additional monitoring data to identify one or more changes in the one or more physiologic parameters of the subject after application of the stimulus to the subject, and providing additional signaling to the at least one stimulating device, the additional signaling comprising instructions to modify the stimulus applied to the subject based on the identified changes in the one or more physiologic parameters.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/097,216, filed on Oct. 26, 2018, which is a national stageapplication of International Application PCT/US2017/30186, filed on Apr.28, 2017, which claims the benefit of and priority to U.S. ProvisionalApplication Ser. No. 62/329,358, filed on Apr. 29, 2016, and to U.S.Provisional Application Ser. No. 62/453,012, filed on Feb. 1, 2017, theentire contents of which are incorporated by reference herein for allpurposes.

TECHNICAL FIELD

The present disclosure relates to the field of physiologic monitoringand, more particularly, to devices and systems for monitoring and/ormanagement of physiologic parameters of a subject.

BACKGROUND

Physiologic monitoring is performed for a range of purposes. Existingtechnologies, however, are not without shortcomings.

There is a need to measure physiologic parameters of subjects, reliably,simply, and without cables. As the proliferation of mobile and remotemedicine increases, simplified and unobtrusive means for monitoring thephysiologic parameters of a patient become more important.

Patient compliance is critical to the success of such systems and isoften directly correlated to the ease of use and unobtrusiveness of themonitoring solution used.

Existing monitoring systems are often prone to false alarms, usagerelated failures, unreliable user interfaces, cumbersome interfaces,artifact or electromagnetic interference (EMI) related interference,etc. Such problems decrease productivity of using these systems, canresult in lost data, and lead to dissatisfaction on the part of both thesubject being monitored and the practitioners monitoring the subject. Inthe case of a hospital setting, the continual drone of alarms can leadto alarm fatigue and decreased productivity.

Long term compliance of subjects may suffer due to uncomfortableinterfaces with monitoring devices, involved maintenance or change-overof disposables, painful or itchy reactions to materials in the devices,and the like.

More reliable, redundant, and user friendly systems are needed that canprovide valuable patient data even when operating with limitedsupervision, expert input, or user manipulation.

SUMMARY

One illustrative, non-limiting objective of this disclosure is toprovide systems, devices, methods, and kits for monitoring andmanagement of physiologic parameters of a subject. Another illustrative,non-limiting objective is to provide simplified system for monitoringsubjects. Another illustrative, non-limiting objective is to providecomfortable long term wearable systems for monitoring subjects. Yetanother illustrative, non-limiting objective is to provide systems forfacilitating stimulation of a subject based on monitoring physiologicparameters of the subject.

The above illustrative, non-limiting objectives are wholly or partiallymet by devices, systems, and methods according to the appended claims inaccordance with the present disclosure. Features and aspects are setforth in the appended claims, in the following description, and in theannexed drawings in accordance with the present disclosure.

In some embodiments, a method comprises receiving monitoring data fromat least one sensing device coupled to a subject, analyzing themonitoring data to identify one or more physiologic parameters of thesubject and providing signaling to at least one stimulating device inresponse to the identified physiologic parameters, the signalingcomprising instructions to apply a stimulus to the subject. The methodalso comprises receiving additional monitoring data from the at leastone sensing device, analyzing the additional monitoring data to identifyone or more changes in the one or more physiologic parameters of thesubject after application of the stimulus to the subject, and providingadditional signaling to the at least one stimulating device, theadditional signaling comprising instructions to modify the stimulusapplied to the subject based on the identified changes in the one ormore physiologic parameters. The method is performed by at least oneprocessing device comprising a processor coupled to a memory.

In some embodiments, the at least one processing device comprises a hostdevice wirelessly coupled to the at least one sensing device and the atleast one stimulating device.

In some embodiments, the stimulus comprises an electrical stimulus. Theelectrical stimulus may comprise application of a pulse train. The pulsetrain may comprise a variable or a fixed repetition rate. The pulsetrain in some embodiments comprises at least one pulse having a durationbetween 10 and 20 microseconds and/or a total charge between 10 and 20microcoulombs. The pulse train may comprise two or more pulses havingduration and charge delivery sufficient to stimulate tactile sensationwhile limiting pain fiber stimulation. The additional signalingcomprises instructions to modify at least one of a duration of at leastone pulse in the pulse train and a total charge of the at least onepulse in the pulse train. In some embodiments, the pulse train whenapplied to the subject mimics another stimulus, the other stimuluscomprising at least one of vibration, pain, a wet sensation, heat orcold, taste, tension or stretch, sound, pressure and light. In someembodiments, the pulse train is applied to the subject to amplifyanother stimulus, the other stimulus comprising at least one ofvibration, pain, a wet sensation, heat or cold, taste, tension orstretch, sound pressure and light.

In some embodiments, the stimulating device comprises a plurality ofelectrodes, and the signaling comprises instructions to selectivelyactivate the plurality of electrodes in different locations in a testpattern and to utilize one or more sensors in at least one of thesensing device and the stimulating device to measure a response of thesubject to the stimulus at the different locations in the test pattern.The additional signaling may comprise instructions to apply a stimulususing one or more of the plurality of electrodes at a given locationbased on the measured response of the subject to the stimulus at thedifferent locations in the test pattern.

In some embodiments, analyzing the monitoring data comprises detectingan event based on measured levels of the one or more physiologicparameters, and wherein the stimulus comprises a therapeutic stimulus toremedy the event. The event may comprise a sleep apneic event, and thetherapeutic stimulus may comprise application of stimulus to a plantaraspect of a foot of the subject. The event may comprise determining asleep posture of the subject, and the therapeutic stimulus may compriseapplication of stimulus to alter the sleep posture of the subject.

In some embodiments, analyzing the monitoring data comprises detectingone or more measured values of physiologic parameters indicating that anevent is likely to occur, and the stimulus comprises a therapeuticstimulus to reduce a likelihood that the event will occur.

In some embodiments, the at least one sensing device and the at leastone stimulating device are physically distinct.

In some embodiments, the at least one sensing device comprises a firstsensing device at a first location on the subject and a second sensingdevice at a second location on the subject different than the firstlocation. The first sensing device may be configured to measure a firstphysiologic parameter of the subject at the first location and thesecond sensing device may be configured to measure a second physiologicparameter different than the first physiologic parameter at the secondlocation. The first sensing device and the second sensing device, insome embodiments, are configured to measure a same physiologic parameterat the first location and the second location. Analyzing the data maycomprise utilizing first information obtained from the first sensingdevice and second information obtained from the second device todetermine a difference in height between the first location and thesecond location. The difference in height may be utilized to determine aposture of the subject.

In some embodiments, the at least one stimulating device comprises afirst stimulating device at a first location on the subject and a secondstimulating device at a second location on the subject different thanthe first location. The signaling may comprise instructions to apply afirst stimulus utilizing the first stimulating device at the firstlocation and to apply a second stimulus different than the firststimulus utilizing the second stimulating device at the second location.

In some embodiments, the at least one stimulating device is integratedinto at least one of a patch adhesively attached to the subject, a sock,an insole, a sandal, a shoe an orthotic, a glove, a wrap, a ring, abracelet, an earbud and a face cover.

In some embodiments, the at least one stimulating device is integratedinto a surface configured for contact with the subject. The surfaceconfigured for contact with the subject may comprise a bed.

In some embodiments, the at least one stimulating device is integratedinto a device not contacting the subject. The device not contacting thesubject may comprise at least one of a speaker, a display and a heatingand cooling system.

In some embodiments, the at least one stimulating device comprises adisposable component configured to conform to an anatomy of the subjectand comprising one or more electrodes configured to apply a stimulus tothe subject, and a reusable component configured to interface with thedisposable component, to receive the signaling, and to direct the one ormore electrodes to apply the stimulus in response to the signaling.

In some embodiments, the at least one sensing device comprises aninsulating region configured to interface with skin of a subject, athermally conducting region configured to interface with the skin of thesubject, a plurality of temperature sensors, the plurality oftemperature sensors comprising at least a first temperature sensor inthe insulating region and at least a second temperature sensor in thethermally conducting region, the plurality of temperature sensorsconfigured to measure skin temperature in the insulating region and thethermally conducting region, and one or more environmental sensorsconfigured to measure one or more thermal properties of surroundings ofthe sensing device. Analyzing the data may comprise deriving thermalgradients from readings from two or more of the plurality of temperaturesensors arranged along a vector substantially normal to a surface of theskin of the subject. Analyzing the data may comprise estimating a coretemperature of the subject based on readings from the plurality oftemperature sensors. Estimating the core temperature may comprisederiving the core temperature from a blood temperature measured by thefirst temperature sensor in the insulating region. Estimating the coretemperature may comprise deriving the core temperature from a sweattemperature measured by the first temperature sensor in the sensingregion. The thermal properties of surroundings of the sensing devicemeasured by the one or more environmental sensors may comprise at leastone of humidity, air temperature, air velocity, air turbidity, ambientpressure and ambient light.

In some embodiments, an article of manufacture comprises anon-transitory processor-readable storage medium having stored thereinexecutable program code which, when executed, causes a processing deviceto perform the above-described method.

In some embodiments, an apparatus comprises a processor and a memorycoupled to the processor, the processor being configured to receivemonitoring data from at least one sensing device coupled to a subject,to analyze the monitoring data to identify one or more physiologicparameters of the subject, to provide signaling to at least onestimulating device in response to the identified physiologic parameters,the signaling comprising instructions to apply a stimulus to thesubject, to receive additional monitoring data from the sensing device,to analyze the additional monitoring data to identify one or morechanges in the one or more physiologic parameters of the subject afterapplication of the stimulus to the subject, and to provide additionalsignaling to the stimulating device, the additional signaling comprisinginstructions to modify the stimulus applied to the subject based on theidentified changes in the one or more physiologic parameters.

In some embodiments, the apparatus comprises a host device wirelesslycoupled to the sensing device and the stimulating device.

In some embodiments, the stimulus comprises an electrical stimulus. Theelectrical stimulus may comprise application of a pulse train. The pulsetrain may comprise two or more pulses having duration and chargedelivery sufficient to stimulate tactile sensation while limiting painfiber stimulation. The additional signaling may comprise instructionsfor modifying at least one of a duration of at least one pulse in thepulse train and a total charge of the at least one pulse in the pulsetrain. In some embodiments, the pulse train when applied to the subjectmimics another stimulus, the other stimulus comprising at least one ofvibration, pain, a wet sensation, heat or cold, taste, tension orstretch, sound, pressure and light. In some embodiments, the pulse trainis applied to the subject to amplify another stimulus, the otherstimulus comprising at least one of vibration, pain, a wet sensation,heat or cold, taste, tension or stretch, sound pressure and light.

In some embodiments, the stimulating device comprises a plurality ofelectrodes, and wherein the signaling comprises instructions toselectively activate the plurality of electrodes in different locationsin a test pattern and to utilize one or more sensors in at least one ofthe sensing device and the stimulating device to measure a response ofthe subject to the stimulus at the different locations in the testpattern.

In some embodiments, analyzing the monitoring data comprises detectingan event based on measured levels of the one or more physiologicparameters, and wherein the stimulus comprises a therapeutic stimulus toremedy the event. The event may comprise a sleep apneic event, and thetherapeutic stimulus may comprise application of stimulus to a plantaraspect of a foot of the subject. The event may comprise determining asleep posture of the subject, and the therapeutic stimulus may compriseapplication of stimulus to alter the sleep posture of the subject.

In some embodiments, analyzing the monitoring data comprises detectingone or more measured values of physiologic parameters indicating that anevent is likely to occur, and the stimulus comprises a therapeuticstimulus to reduce a likelihood that the event will occur.

In some embodiments, the sensing device and the stimulating device arephysically distinct.

In some embodiments, a system comprises at least one sensing devicecoupled to a subject, at least one stimulating device coupled to thesubject, and a host device comprising a memory and a processor coupledto the memory, the host device being wirelessly coupled to the at leastone sensing device and the at least one stimulating device. The hostdevice is configured to receive monitoring data from the at least onesensing device, to analyze the monitoring data to identify one or morephysiologic parameters of the subject, to provide signaling to the atleast one stimulating device in response to the identified physiologicparameters, the signaling comprising instructions to apply a stimulus tothe subject, to receive additional monitoring data from the at least onesensing device, to analyze the additional monitoring data to identifyone or more changes in the one or more physiologic parameters of thesubject after application of the stimulus to the subject, and to provideadditional signaling to the at least one stimulating device, theadditional signaling comprising instructions to modify the stimulusapplied to the subject based on the identified changes in the one ormore physiologic parameters.

In some embodiments, the at least one sensing device comprises a firstsensing device at a first location on the subject and a second sensingdevice at a second location on the subject different than the firstlocation. The first sensing device may be configured to measure a firstphysiologic parameter of the subject at the first location and thesecond sensing device may be configured to measure a second physiologicparameter different than the first physiologic parameter at the secondlocation. The first sensing device and the second sensing device may beconfigured to measure a same physiologic parameter at the first locationand the second location. Analyzing the data may comprise utilizing firstinformation obtained from the first sensing device and secondinformation obtained from the second device to determine a difference inheight between the first location and the second location. Thedifference in height may be utilized to determine a posture of thesubject.

In some embodiments, the at least one stimulating device comprises afirst stimulating device at a first location on the subject and a secondstimulating device at a second location on the subject different thanthe first location. The signaling may comprise instructions to apply afirst stimulus utilizing the first stimulating device at the firstlocation and to apply a second stimulus different than the firststimulus utilizing the second stimulating device at the second location.

In some embodiments, the at least one stimulating device is integratedinto at least one of a patch adhesively attached to the subject, a sock,an insole, a sandal, a shoe, an orthotic, a glove, a wrap, a ring, abracelet, an earbud and a face cover.

In some embodiments, the at least one stimulating device is integratedinto a surface configured for contact with the subject.

In some embodiments, the at least one sensing device is integrated intoa device not contacting the subject.

In some embodiments, the at least one stimulating device comprises adisposable component configured to conform to an anatomy of the subjectand comprising one or more electrodes configured to apply a stimulus tothe subject, and a reusable component configured to interface with thedisposable component, to receive the signaling, and to direct the one ormore electrodes to apply the stimulus in response to the signaling.

In some embodiments, the at least one sensing device comprises aninsulating region configured to interface with skin of a subject, athermally conducting region configured to interface with the skin of thesubject, a plurality of temperature sensors, the plurality oftemperature sensors comprising at least a first temperature sensor inthe insulating region and at least a second temperature sensor in thethermally conducting region, the plurality of temperature sensorsconfigured to measure skin temperature in the insulating region and thethermally conducting region, and one or more environmental sensorsconfigured to measure one or more thermal properties of surroundings ofthe sensing device.

BRIEF DESCRIPTION OF THE DRAWINGS

Several aspects of the disclosure can be better understood withreference to the following drawings. In the drawings, like referencenumerals designate corresponding parts throughout the several views.

FIG. 1 illustrates aspects of a modular physiologic monitoring system,according to an embodiment of the invention.

FIG. 2 illustrates an adhesively-applied stimulating device comprising apatch-module pair, according to an embodiment of the invention.

FIG. 3 illustrates a patch-module pair with vibratory stimulus means,according to an embodiment of the invention.

FIG. 4 illustrates a patch-module pair with thermal stimulus means,according to an embodiment of the invention.

FIG. 5 illustrates a patch-module pair with tactile stimulus means,according to an embodiment of the invention.

FIG. 6 illustrates a sock-like stimulating device, according to anembodiment of the invention.

FIG. 7 illustrates arrangements of electrodes for a stimulating deviceconfigured to interface with a foot of a subject, according to anembodiment of the invention.

FIG. 8 illustrates regions of the foot for application of stimulus,according to an embodiment of the invention.

FIG. 9 illustrates regions of the foot for application of stimulus,according to an embodiment of the invention.

FIG. 10 illustrates a stimulating device with a disposable component anda reusable component, according to an embodiment of the invention.

FIGS. 11a-11e illustrate electrode layouts, according to an embodimentof the invention.

FIGS. 12a-12c illustrates a patch-module pair that is applied to thesole of a foot of a subject, according to an embodiment of theinvention.

FIG. 13 illustrates a glove-like stimulating device, according to anembodiment of the invention.

FIG. 14 illustrates wrap-like and earbud sensing and stimulatingdevices, according to an embodiment of the invention.

FIG. 15 illustrates a ring- or band-like stimulating device, accordingto an embodiment of the invention.

FIG. 16 illustrates a face cover stimulating device, according to anembodiment of the invention.

FIG. 17 illustrates a stimulating device incorporated into a contactsurface and non-contacting stimulating devices, according to anembodiment of the invention.

FIG. 18 illustrates sleep postures, according to an embodiment of theinvention.

FIG. 19 illustrates multiple sensing devices attached to a subject formeasuring orientation, according to an embodiment of the invention.

FIG. 20 illustrates sensing devices for measuring neck alignment,according to an embodiment of the invention.

FIG. 21 illustrates a patch sensing device for measuring coretemperature, according to an embodiment of the invention.

FIG. 22 illustrates a patch with a reusable component for monitoringpressure along a region of a subject, according to an embodiment of theinvention.

FIG. 23 illustrates a plot of applied pressure, according to anembodiment of the invention.

FIGS. 24a-24c illustrates a modular physiologic monitoring system,according to an embodiment of the invention.

FIG. 25 illustrates a state diagram for monitoring a subject, accordingto an embodiment of the invention.

FIG. 26 illustrates a state diagram for monitoring a subject, accordingto an embodiment of the invention.

FIG. 27 illustrates a method for monitoring and management ofphysiologic parameters of a subject, according to an embodiment of theinvention.

FIG. 28 illustrates a patch-module pair attached to the skin of asubject, according to an embodiment of the invention.

FIGS. 29a and 29b illustrate holding force of a patch-module pairattached to the skin of a subject, according to an embodiment of theinvention.

FIGS. 30 and 31 illustrate raw data obtained from a patch-module pair,according to an embodiment of the invention.

FIG. 32 illustrates communications in a modular physiologic monitoringsystem, according to an embodiment of the invention.

FIG. 33 illustrates a profile stack used for communications in a modularphysiologic monitoring system, according to an embodiment of theinvention.

DETAILED DESCRIPTION

Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings; however, thedisclosed embodiments are merely examples of the disclosure and may beembodied in various forms. Therefore, specific structural and functionaldetails disclosed herein are not to be interpreted as limiting, butmerely as a basis for the claims and as a representative basis forteaching one skilled in the art to variously employ the presentdisclosure in virtually any appropriately detailed structure. Likereference numerals may refer to similar or identical elements throughoutthe description of the figures

A modular physiologic monitoring system in accordance with the presentdisclosure for assessing one or more physiologic parameters of a subject(e.g., a human subject, a patient, an athlete, a trainer, an animal,such as equine, canine, porcine, bovine, etc.) with a body may includeone or more patches, each patch adapted for attachment to the body ofthe subject (e.g., attachable to the skin thereof, reversiblyattachable, adhesively attachable, with a disposable interface and areusable module, etc.). In aspects, the physiologic monitoring systemmay include one or more modules, and each module may include a powersource (e.g., a battery, a rechargeable battery, an energy harvestingtransducer, microcircuit, and an energy reservoir, a thermal gradientharvesting transducer, a kinetic energy harvesting transducer, a radiofrequency energy harvesting transducer, a fuel cell, a biofuel cell,etc.), signal conditioning circuitry, communication circuitry, one ormore sensors, or the like, configured to generate one or more signals(e.g., physiologic and/or physical signals), stimulus, etc..

One or more of the patches may include one or more interconnects,configured and dimensioned so as to couple with one or more of themodules, said modules including a complimentary interconnect configuredand dimensioned to couple with the corresponding patch. The patch mayinclude a bioadhesive interface for attachment to the subject, themodule retainable against the subject via interconnection with thepatch.

In aspects, the patch may be configured so as to be single use (e.g.,disposable). The patch may include a thin, breathable, stretchablelaminate. In aspects, the laminate may include a substrate, abioadhesive, one or more sensing or stimulating elements in accordancewith the present disclosure, and one or more interconnects for couplingone or more of the sensing elements with a corresponding module.

In aspects, to retain a high degree of comfort and long termwear-ability of the patch on a subject, to limit interference withnormal body function, to limit interference with joint movement, or thelike, the patch may be sufficiently thin and frail, such that it may notsubstantially retain a predetermined shape while free standing. Such adefinition is described in further detail below. The patch may beprovided with a temporary stiffening film to retain the shape thereofprior to placement of the patch onto the body of a subject. Once adheredto the subject, the temporary stiffening film may be removed from thepatch. While the patch is adhered to the subject, the shape andfunctionality of the patch may be substantially retained. Upon removalof the patch from the subject, the, now freestanding patch issufficiently frail such that the patch can no longer substantiallyretain the predetermined shape (e.g., sufficiently frail such that thepatch will not survive in a free standing state). In aspects, stretchapplied to the patch while removing the patch from the subject mayresult in snap back once the patch is in a freestanding state thatrenders such a patch to crumple into a ball and no longer function.

In aspects, the patch may include a film (e.g., a substrate), withsufficiently high tear strength, such that, as the patch is peeled fromthe skin of a subject, the patch does not tear. In aspects, the ratiobetween the tear strength of the patch and the peel adhesion strength ofthe patch to skin (e.g., tear strength: peel adhesion strength), isgreater than 8:1, greater than 4:1, greater than 2:1, or the like. Sucha configuration may be advantageous so as to ensure the patch may beeasily and reliably removed from the subject after use without tearing.

In aspects, the patch may include a bioadhesive with peel tack tomammalian skin of greater than 0.02 Newtons per millimeter (N/mm),greater than 0.1N/mm, greater than 0.25N/mm, greater than 0.50N/mm,greater than 0.75N/mm, greater than 2N/mm, or the like. Such peel tackmay be approximately determined using an American Society for Testingand Materials (ASTM) standard test, ASTM D3330: Standard test method forpeel adhesion of pressure-sensitive tape.

In aspects, the patch may exhibit a tear strength of greater than0.5N/mm, greater than 1N/mm, greater than 2N/mm, greater than 8N/mm, orthe like. Such tear strength may be approximately determined using anASTM standard test, ASTM D624: Standard test method for tear strength ofconventional vulcanized rubber and thermoplastic elastomers.

In aspects, the patch may be provided with a characteristic thickness,of less than 50 micrometer (μm), less than 25 μm, less than 12 μm, lessthan 8 μm, less than 4 μm, or the like. Yet, in aspects, a balancebetween the thickness, stiffness, and tear strength may be obtained soas to maintain sufficiently high comfort levels for a subject,minimizing skin stresses during use (e.g., minimizing skin stretchrelated discomfort and extraneous signals as the body moves locallyaround the patch during use), minimizing impact on skin health,minimizing risk of nicking during use, and minimizing risk of macerationto the skin of a subject, while limiting risk of tearing of the patchduring removal from a subject, etc.

In aspects, the properties of the patch may be further altered so as tobalance the hydration levels of one or more hydrophilic or amphiphiliccomponents of the patch while attached to a subject. Such adjustment maybe advantageous to prevent over hydration or drying of an ionicallyconducting component of the patch, to manage heat transfer coefficientswithin one or more elements of the patch, to manage salt retention intoa reservoir in accordance with the present disclosure, and/or migrationduring exercise, to prevent pooling of exudates, sweat, or the like intoa fluid measuring sensor incorporated into the patch or associatedmodule, etc. In aspects, the patch or a rate determining componentthereof may be configured with a moisture vapor transmission rate ofbetween 200 grams per meter squared per 24 hours (g/m²/24 hrs) and20,000 g/m²/24 hrs, between 500 g/m²/24 hrs and 12,000 g/m²/24 hrs,between 2,000 g/m²/24 hrs and 8,000 g/m²/24 hrs, or the like.

Such a configuration may be advantageous for providing a comfortablewearable physiologic monitor for a subject, while reducing materialwaste and/or cost of goods, preventing contamination or disease spreadthrough uncontrolled re-use, and the like.

In aspects, one or more patches and/or modules may be configured forelectrically conducting interconnection, inductively coupledinterconnection, capacitively coupled interconnection, with each other.In the case of an electrically conducting interconnect, each patch andmodule interconnect may include complimentary electrically conductingconnectors, configured and dimensioned so as to mate together uponattachment. In the case of an inductively or capacitively coupledinterconnect, the patch and module may include complimentary coils orelectrodes configured and dimensioned so as to mate together uponattachment.

Each patch or patch-module pair may be configured as a sensing device tomonitor one or more local physiologic and/or physical parameters of theattached subject (e.g., local to the site of attachment, etc.), localenvironment, combinations thereof, or the like, and to relay suchinformation in the form of signals to a host device (e.g., via awireless connection, via a body area network connection, or the like),one or more patches or modules on the subject, or the like. Each patchand/or patch-module pair may also or alternatively be configured as astimulating device to apply a stimulus to the subject in response tosignaling from the host device, the signaling being based on analysis ofthe physiologic and/or physical parameters of the subject measured bythe sensing device(s).

In aspects, the host device may be configured to coordinate informationexchange to/from each module and/or patch, and to generate one or morephysiologic signals, physical signals, environmental signals, kineticsignals, diagnostic signals, alerts, reports, recommendation signals,commands, combinations thereof, or the like for the subject, a user, anetwork, an electronic health record (EHR), a database (e.g., as part ofa data management center, an EHR, a social network, etc.), a processor,combinations thereof, or the like.

In aspects, a system in accordance with the present disclosure mayinclude a plurality of substantially similar modules (e.g., generallyinterchangeable modules, but with unique identifiers), for coupling witha plurality of patches, each patch, optionally different from the otherpatches in the system (e.g., potentially including alternative sensors,sensor types, sensor configurations, electrodes, electrodeconfigurations, etc.). Each patch may include an interconnect suitablefor attachment to an associated module. Upon attachment of a module to acorresponding patch, the module may validate the type and operation ofthe patch to which it has been mated. In aspects, the module may theninitiate monitoring operations on the subject via the attached patch,communicate with one or more patches on the subject, a hub, etc. Thedata collection from each module may be coordinated through one or moremodules and/or with a host device in accordance with the presentdisclosure. The modules may report a time stamp along with the data inorder to synchronize data collection across multiple patch-module pairson the subject, between subjects, etc. Thus, if a module is to bereplaced, a hot swappable replacement (e.g., replacement during amonitoring procedure) can be carried out easily by the subject, acaregiver, practitioner, etc. during the monitoring process. Such aconfiguration may be advantageous for performing redundant, continuousmonitoring of a subject, and/or to obtain spatially relevant informationfrom a plurality of locations on the subject during use.

In aspects, the modules and/or patches may include correspondinginterconnects for coupling with each other during use. The interconnectsmay include one or more connectors, configured such that the modules andpatches may only couple in a single unique orientation with respect toeach other. In aspects, the modules may be color coded by function. Atemporary stiffening element attached to a patch may includeinstructions, corresponding color coding, etc. so as to assist a user orsubject with simplifying the process of monitoring.

In addition to physiologic monitoring, one or more patches and/ormodules may be used to provide a stimulus to the subject, as will bedescribed in further detail below.

A modular physiologic monitoring system, in some embodiments, includesone or more sensing devices, which may be placed or attached to one ormore sites on the subject. Alternatively or additionally, one or moresensing devices may be placed “off” the subject, such as one or moresensors (e.g., cameras, acoustic sensors, etc.) that are not physicallyattached to the subject. The sensing devices are utilized to establishwhether or not an event is occurring and to determine one or morecharacteristics of the event by monitoring and measuring physiologicparameters of the subject. The determination of whether an event hasoccurred or is occurring may be made by a device that is at leastpartially external and physically distinct from the one or more sensingdevices, such as a host device in wired or wireless communication withthe sensing devices as described below with respect to FIG. 1. Themodular physiologic monitoring system includes one or more stimulatingdevices, which again may be any combination of devices that are attachedto the subject or placed “off” the subject, to apply a stimulus to thesubject to treat the event, to prevent the event from transition from afirst form into a second form, to interrupt the event, to stimulate atype of input to the subject with an alternative form of energy (e.g.,stimulating one or more of thermal input, vibration input, mechanicalinput, a compression or the like with an electrical input), etc.

The sensing devices of a modular physiologic monitoring system, such aspatch-module pairs described below with respect to FIG. 1, may be used:to monitor one or more physiologic functions or parameters of a subject,to monitor one or more disease states of a subject; to monitor the stateof one or more tissue sites (e.g., tissue health, pressure applied tothe tissue, etc.) of a subject; to monitor one or more orientations of aregion of a subject with respect to gravity, with respect to one or moreother regions of the body of the subject (e.g., back posture, backorientation, neck orientation, spinal rotation, hip rotation, neckrotation, etc.); to monitor any of the above in combination withpostural information (e.g., monitoring local muscle activity or spasm incombination with postural information), etc. The sensing devices of themodular physiologic monitoring system, or a host device configured toreceive data or measurements from the sensing devices, may be utilizedto monitor for one or more events (e.g., through analysis of signalsmeasured by the sensing devices, from metrics derived from the signals,etc.). The stimulating devices of the modular physiologic monitoringsystem may be configured to deliver one or more stimuli (e.g.,electrical, vibrational, acoustic, visual, etc.) to the subject. Thestimulating devices may receive a signal from one or more of the sensingdevices or a host device, and provide the stimulation in response to thereceived signal.

FIG. 1 shows aspects of a modular physiologic monitoring system inaccordance with the present disclosure. FIG. 1 shows a subject 1 with aseries of patches and/or patch-module pairs each in accordance with thepresent disclosure attached to the subject 1 at sites described below, ahost device 145 in accordance with the present disclosure, afeedback/user device 147 in accordance with the present disclosuredisplaying some data 148 based upon signals obtained from the subject 1,and one or more feedback devices 135, 140, in accordance with thepresent disclosure configured to convey to the subject 1 one or moreaspects of the signals or information gleaned therefrom. In someembodiments, the feedback devices 135, 140 may also or alternativelyfunction as stimulating devices. The host device 145, the user device147, the patches and/or patch-module pairs, and/or the feedback devices135, 140 may be configured for wireless communication 146, 149 during amonitoring session.

In aspects, a patch-module pair may be adapted for placement almostanywhere on the body of a subject 1. As shown in FIG. 1, some sites mayinclude attachment to the cranium or forehead 131, the temple, the earor behind the ear 50, the neck, the front, side, or back of the neck137, a shoulder 105, a chest region with minimal muscle mass 100,integrated into a piece of ornamental jewelry 55 (may be a host, a hub,a feedback device, etc.), arrangement on the torso 110 a-c, arrangementon the abdomen 80 for monitoring movement or breathing, below the ribcage 90 for monitoring respiration (generally on the right side of thebody to substantially reduce EKG influences on the measurements), on amuscle such as a bicep 85, on a wrist 135 or in combination with awearable computing device 60 on the wrist (e.g., a smart watch, afitness band, etc.), on a buttocks 25, on a thigh 75, on a calf muscle70, on a knee 35 particularly for proprioception based studies andimpact studies, on a shin 30 primarily for impact studies, on an ankle65, over an Achilles tendon 20, on the front or top of the foot 15, on aheel 5, or around the bottom of a foot or toes 10. Other sites forplacement of such devices are envisioned. Selection of the monitoringand/or stimulating sites is generally determined based upon the intendedapplication of the patch-module pairs described herein.

Additional placement sites on the abdomen, perineal region 142 a-c,genitals, urogenital triangle, anal triangle, sacral region, inner thigh143, or the like may be advantageous in the assessment of autonomicneural function of a subject. Such placements regions may beadvantageous for assessment of PNS activity, somatosensory function,assessment of SNS functionality, etc.

Placement sites on the wrist 144 a, hand 144 b or the like mayadvantageous for interacting with a subject, such as via performing astress test, performing a thermal stress test, performing a tactilestress test, monitoring outflow, afferent traffic, efferent traffic,etc.

Placement sites on the nipples, areola, lips, labia, clitoris, penis,the anal sphincter, levator ani muscle, over the ischiocavernous muscle,deep transverse perineal muscle, labium minus, labium majus, one or morenerves near the surface thereof, posterior scrotal nerves, perinealmembrane, perineal nerves, superficial transverse perineal nerves,dorsal nerves, inferior rectal nerves, etc. may be advantageous forassessment of autonomic neural ablation procedures, autonomic neuralmodulation procedures, assessment of the PNS of a subject, assessment ofsexual dysfunction of a subject, etc.

Placement sites on the face 141, over ocular muscles, near the eye, overa facial muscle (e.g., a nasalis, temporalis, zygonaticus minor/major,orbicularis oculi, occipitofrontalis), near a nasal canal, over a facialbone (e.g., frontal process, zygomatic bone/surface, zygomaticofacialforeman, malar bone, nasal bone, frontal bone, maxilla, temporal bone,occipital bone, etc.), may be advantageous to assess ocular function,salivary function, sinus function, interaction with the lips,interaction with one or more nerves of the PNS (e.g., interacting withthe vagus nerve within, on, and/or near the ear of the subject), etc.

In aspects, a system in accordance with the present disclosure may beconfigured to monitor one or more physiologic parameters of the subject1 before, during, and/or after one or more of, a stress test,consumption of a medication, exercise, a rehabilitation session, amassage, driving, a movie, an amusement park ride, sleep, intercourse, asurgical, interventional, or non-invasive procedure, a neural remodelingprocedure, a denervation procedure, a sympathectomy, a neural ablation,a peripheral nerve ablation, a radio-surgical procedure, aninterventional procedure, a cardiac repair, administration of ananalgesic, a combination thereof, or the like. In aspects, a system inaccordance with the present disclosure may be configured to monitor oneor more aspects of an autonomic neural response to a procedure, confirmcompletion of the procedure, select candidates for a procedure, followup on a subject after having received procedure, assess the durabilityof a procedure, or the like (e.g., such as wherein the procedure is arenal denervation procedure, a carotid body denervation procedure, ahepatic artery denervation procedure, a LUTs treatment, a bladderdenervation procedure, a urethral treatment, a prostate ablation, aprostate nerve denervation procedure, a cancer treatment, a pain block,a neural block, a bronchial denervation procedure, a carotid sinusneuromodulation procedure, implantation of a neuromodulation device,tuning of a neuromodulation device, etc.).

Additional details regarding modular physiologic monitoring systems,kits and methods are further described in PCT application serial no.PCT/US2014/041339, published as WO 2014/197822 and titled “ModularPhysiologic Monitoring Systems, Kits, and Methods,” and PCT applicationserial no. PCT/US2015/043123, published as WO 2016/019250 and titled“Modular Physiologic Monitoring Systems, Kits, and Methods, thedisclosures of which are incorporated by reference herein in theirentirety.

Various embodiments are described below with respect to utilizing amodular physiologic monitoring system, kits or methods for monitoringand management of sleep quality or one or other aspects of sleep of asubject and to monitoring and management of body temperature andsystemic fatigue of a subject. It is to be appreciated, however, thatembodiments are not limited to these specific use cases but are insteadmore broadly applicable to monitoring and management of one or morephysiologic parameters of a subject.

In some embodiments, modular physiologic monitoring systems may beconfigured to treat sleep state disorders, such as sleep apnea. Amodular physiologic monitoring system may utilize one or more sensingdevices to detect an event or condition associated with sleep apnea and,in response to such detection, utilize one or more stimulating devicesto apply therapy to the subject.

The sensing devices and the stimulating devices may be physicallydistinct, such as being physically attached to a subject at varyinglocations. For example, the sensing devices may be one or more of thepatch-module pairs described above with respect to FIG. 1, such as thepatch-module pair 137 adapted for placement on the chest, neck, or upperback of the subject 1 for assessing airway integrity and blockage, thepatch-module pairs 110 a-c adapted for placement on the torso forassessing an electrocardiogram (ECG) or respiratory electromyogram (EMG)of the subject 1, the patch-module pair 131 adapted for placement on thehead or forehead for assessing electroencephalogram (EEG),electro-oculogram (EOG) or a sleep state of the subject 1, or variousother patch-module pairs described above with respect to FIG. 1 whichmay be used to measure movement at one or more desired locations,patch-module pairs adapted for placement on a back, shoulders, lowerback, etc. of the subject 1 for assessing muscle spasm or posture, twoor more patch-module pairs on the subject 1 for assessing posturalorientation, one or more patch-module pairs placed near the left orright sides of the torso at the base of the rib cage so as to monitordiaphragmatic breathing, etc. In addition, in some embodiments devicesother than the patch-module pairs described above with respect to FIG. 1may be used as sensing devices, such as devices for measuring a 12-leadECG, one or more cameras for observing posture or postural orientation,one or more microphones or other acoustic sensors to detect changes inbreathing, snoring, etc.

One or more of the patch-module pairs described above with respect toFIG. 1 may also or alternatively function as stimulating devices. Forexample, patch-module pairs 5, 10, 15 20 adapted for placement invarious regions on and around the foot of the subject 1 may be used forapplying a stimulus to the subject 1 in response to detecting acondition or event using one or more of the sensing devices. Similar tothe sensing devices, the stimulating devices are not limited to beingone of the patch-module pairs described above with respect to FIG. 1. Inother embodiments, various other types of stimulating devices may beutilized as will be described in further detail below. For example,stimulating devices may take on various form factors in differentembodiments. As described above with respect to FIG. 1, a stimulatingdevice may be in the form of a patch-module pair, a wrist band orbracelet, ring, necklace, anklet, ocular feedback device, etc. Astimulating device may also or alternatively be provided in the form ofa glove, sock, orthotic, etc. as will be described in further detailbelow.

As discussed above, embodiments are not limited to monitoring andmanagement of the sleep state of a subject. In some embodiments, sensingdevices may be used to detect impact or other conditions or events at aregion of a subject which has no or little feeling, with the stimulatingdevices being utilized to apply a stimulus at another region of thesubject which has comparatively greater feeling or sensation. As oneexample, one or more patch-module pairs 30 or 35 adapted for placementon the shin and knee of the subject 1 may be used as sensing devices todetect impact to the subject 1, with the patch-module pair 50 adaptedfor placement on or around the ear of the subject 1 being utilize toapply an auditory stimulus to the subject 1 on detecting impact to theknee or shin of the subject 1.

For managing sleep apnea, sleep state, exercise, physical assertion orother aspects of a subject, a number of therapeutic stimuli may beutilized by the stimulating devices in a modular physiologic monitoringsystem. Such stimuli may be positive (reinforcement) or negative(inhibitory). Electric discharge is one type of stimuli that may beutilized, whereby one or more of the stimulating devices in the modularphysiologic monitoring system may deliver electrical energy to a bodylocation in response to detecting an event such as an apneic episode oran obstructive apneic event using one or more of the sensing devices inthe modular physiologic monitoring system. The sensing devices maymeasure any of a number of physiologic parameters of the subject,including but not limited to respiration depth or rate, respirationcharacter, diaphragmatic movement or strength, EMG, extraocular muscles(EOM), acoustic or vibrational detection of obstruction, etc.

Once an event or condition is detected utilizing one or more of thesensing devices, the modular physiologic monitoring system can deliver astimulus to a body part, such as the soles of the feet, the chest, thepalms, the face/forehead, genitals, neck, ear, mastoid region, etc.using one or more of the stimulating devices. The stimulation may beelectrical stimulation, such as a tactile sensation that avoidsstimulating local pain fibers. The stimulation may have a shortduration, such as 10-20 microseconds (μs) in some embodiments. Thestimulation may also take the form of a pulse train having a variable orfixed repetition rate. The stimulating devices may utilize one or moremonopolar, bipolar or multipolar electrodes to deliver the stimulus. Insome embodiments, the stimulating devices are provided with a constantcurrent supply, thus allowing the stimulating devices to have definedcharge delivery, the capability of short duration pulses (e.g., 10-20μs), and be configured to design the duration and charge delivery tostimulate tactile sensation while limiting or completely avoiding painfiber stimulation. Pain fiber stimulation in some embodiments is limitedor prevented through controlling the total charge of the electricalstimulation. The total charge, for example, may be limited to a maximumof 10-20 microcoulombs (μC). The electrical stimulation may also oralternatively be delivered as a multiple pulse train, a burststimulation or other configuration. The low total charge to avoid painfiber sensation is designed to be below the threshold for pain butenough to be sensed and reacted.

The sensing devices, as discussed above, may be configured to measure awide variety of physiologic parameters of the subject including but notlimited to ECG, EEG and/or EMG for measuring diaphragmatic parameterssuch as displacement, strength of contraction, EMG measurements, etc.,hemoglobin (Hb) saturation, oxygen/carbon dioxide (O₂/CO₂) ratio fromrespiration, acoustic measurements (e.g., to sense airway obstruction,snoring, etc.), etc. The sensing devices may be in communication with anexternal sensing system or device, such as the host device 145 describedabove with respect to the FIG. 1 modular physiologic monitoring system.The host device 145 may also be in communication with one or more of thestimulating devices. Such a system may therefore provide closed loopsensing-stimulation, where the stimulus is based on algorithmicdetermination and/or classification of apnea events based on physiologicparameters measured by the sensing devices. In some embodiments, apneaevents are detected based on respiration rate or period (e.g., timebetween breaths) and/or the depth of respiration and associatedphysiologic consequences based on data obtained using the sensingdevices, followed by feedback or stimulus provided via the stimulatingdevices, where the feedback or stimulus is provided until data obtainedusing the sensing devices indicates that a satisfactory response hasbeen achieved.

In some non-limiting examples, the sensing device(s) and the stimulatingdevice(s) may be in direct communication with each other. In onenon-limiting example, the stimulating device may provide a host wirelessfunction while one or more sensing devices may include a peripheralwireless function, the stimulating device configured so as to managecommunication with the plurality of sensing devices.

In some embodiments wherein the stimulating device includes one or morestimulating electrodes, the stimulation electrodes may be adapted forplacement on the skin of a subject, such as skin at or near the foot(e.g., the sole or other dermatomes of the foot), at or near the auricleor posterior auricular nerves, at or near the internal auditory canal,etc. A stimulating device including one or more stimulating electrodesmay be in the form of a patch and/or a patch-module pair or anotherdevice with an adhesive or other attachment for connection to the areaor region of interest on the body. One or more stimulating electrodesmay be monopolar, bipolar or multipolar.

The sensing and/or stimulating devices of a modular physiologicmonitoring system may be configured for radio frequency (RF) or otherwireless and/or wired connection with one another and/or a host device.Such RF or other connection may be used to transmit or receive feedbackparameters or other signaling between the sensing and stimulatingdevices. The feedback, for example, may be provided based onmeasurements of physiologic parameters that are obtained using thesensing devices to determine when apneic or obstruction events areoccurring. Various thresholds for stimulation that are applied by thestimulating devices may, in some embodiments, be determined based onsuch feedback. Thresholds may relate to the amplitude or frequency ofelectric or other stimulation. Thresholds may also be related to whetherto initiate stimulation by the stimulating devices based on thefeedback. For example, such thresholds may relate to physiologicconsequences (e.g., such as low saturation).

Various stimulation algorithms may be activated based on the feedback.In some embodiments, the stimulating devices may act as a “respiratorypacemaker” with multiple modes, including sensing or on-demand stimulusor free running stimulus. In such embodiments, the respiration of thesubject may be influenced by the stimulation provided by the stimulatingdevice. Such capability may be advantageous to restart the breathingprocess of a subject, to pace the breathing of the subject, to awakenthe subject, to avert an apneic event, or the like.

During and/or after stimulus is applied with the stimulating devices,the sensing devices may monitor the physiologic response of the subject.If stimulation is successful, stimulation may be discontinued. If apnearemains, stimulation may be continued and possibly altered (e.g.,increasing a level or amplitude of an applied stimulus, etc.). Thephysiologic response may be monitored and the decision whether tocontinue or discontinue and/or whether to adjust stimulation mayfunction on a breath by breath basis. The amplitude of stimulation maybe adjusted if low stimulation levels are insufficient to achieve adesired response. As described above, it may be desired to provideelectrical stimulation which stimulates tactile sensation while avoidingor limiting pain fiber sensation. Thus, in some embodiments, stimulusmay start at a relatively low amplitude to limit pain fiber sensationand may be increased (either continuously or at discrete levels) untilthe electrical stimulus is sufficient to achieve the desired response.Thus, the electrical stimulus advantageously can provide tactilestimulation while limiting pain fiber sensation. In some embodiments,electrical stimulation may be in the form of electric shocks which areshort, potent and repeat with increasing intensity until a desiredresponse is achieved.

In some embodiments, a user of the modular physiologic monitoring systemmay set preferences for the stimulus type, level, and/or otherwisepersonalize the sensation during a setup period or at any point duringuse of the modular physiologic monitoring system. The user of themodular physiologic monitoring system may be the subject being monitoredand stimulated by the sensing devices and stimulating devices, or adoctor, nurse, physical therapist, medical assistant, caregiver, etc. ofthe subject being monitored and stimulated. The user may also have theoption to disconnect or shut down the modular physiologic monitoringsystem at any time, such as via operation of a switch, pressuresensation, voice operated instruction, etc.

Although described above with respect to measuring and managing sleepapnea, modular physiologic monitoring systems described herein may alsobe used more generally in measuring and managing sleep quality includingnon-apneic low quality sleep. The assessment of low sleep quality may bebased on assessment of a number of physiologic parameters, such as EEG,EKG, EMG, respiratory rate or depth, etc. Low sleep quality events maybe detected based on data obtained using the sensing devices andfeedback or stimulus may be provided to the subject in response todetection of low sleep quality events utilizing the stimulating devices.

In one non-limiting embodiment, a system for treating bruxism may beformed, the system including one or more sensing devices placed onto theforehead, neck, jaw, or mastoid region of a subject, the sensing devicesconfigured so as to monitor an electromyographic signal from the subjectduring use, the EMG signal pertaining to the grinding of teeth,clenching of the jaw of the subject, etc. The system may include one ormore stimulating devices, the stimulating devices configured tostimulate the subject to avert a bruxism event, to alter a clenching orgrinding event, or the like. In such a way, the feedback provided by thestimulation may affect the behavior of the subject, retrain the subjectto avoid the unwanted behavior, etc.

In some embodiments, algorithms for determining whether a sleep apneaevent or other type of event has occurred may be based on a number ofinputs. The various inputs may be measured directly utilizing one ormore of the sensing devices, or may be derived based at least in partusing measurements from one of or a combination of sensing devices.Inputs used in some embodiments include respiratory rate, respiratorydepth, diaphragm movement and excursion, apnea duration, O₂ saturation,grinding event, sleep state, dream state, snoring or obstruction, heartrate (HR) and/or HR variability, EEG (e.g., alpha, beta, delta, etc.),EOG, EOM, etc.

Based on detected events, a modular physiologic monitoring system mayprovide a number of outputs to one or more of the stimulating devicesand/or one or more of the sensing devices. Outputs may include, by wayof example, feedback or stimulus as described above, which may bepositive and/or negative. Biofeedback output may be provided for bettersleep, and various diagnostics may be used for determining sleep qualityand possible remedial measures to improve sleep quality. Suchdiagnostics include EKG, EEG (e.g., such as synchronizing stimuli), EOM,sweating, motion or body positioning, EMG (e.g., to measure or quantifya relaxed state of a subject, activation of target muscle groups, eyemovement, rapid eye movement, diaphragmatic activation, muscle tone,tongue movement, muscle twitching, etc.), dreaming,sympathetic-parasympathetic state and/or responses, core and vitalsmeasurements, core temperature, sudomotor activity, etc.

Stimulus or feedback which may be provided via one or more stimulatingdevices in a modular physiologic monitoring system may be in variousforms, including physical stimulus (e.g., electrical, thermal,vibrational, pressure, stroking, a combination thereof, or the like),optical stimulus, acoustic stimulus, etc.

Physical stimulus may be provided in the form of negative feedback, suchas in a brief electric shock or impulse as described above. Data orknowledge from waveforms applied in conducted electrical weapons (CEWs),such as in electroshock devices, may be utilized to avoid painfulstimulus. Physical stimulus may also be provided in the form of positivefeedback, such as in evoking pleasurable sensations by combiningnon-painful electrical stimulus with pleasant sounds, lighting, smells,etc. Physical stimulus is not limited solely to electrical shock orimpulses. In other embodiments, physical stimulus may be provided byadjusting temperature or other stimuli, such as in providing a burst ofcool or warm air, a burst of mist, vibration, tension, stretch,pressure, etc.

Feedback provided via physical stimulus as well as other stimulusdescribed herein may be synchronized with, initiated by or otherwisecoordinated or controlled in conjunction with an apnea monitor. Theapnea monitor, which may be in the form of a host device and/or one ormore sensing devices, can be connected to the stimulating devicesphysically (e.g., via one or more wires or other connectors), wirelessly(e.g., via radio or other wireless communication), etc. Physicalstimulus may be applied to various regions of a subject, including butnot limited to the wrist, soles of the feet, palms of the hands,nipples, forehead, ear, mastoid region, the skin of the subject, etc.

Optical stimulus may be provided via one or more stimulating devices asvarious psychoacoustics. The optical stimulus may be positive ornegative (e.g., by providing pleasant or unpleasant lighting or othervisuals). Acoustic stimulus similarly may be provided via one or morestimulating devices, as positive or negative feedback (e.g., byproviding pleasant or unpleasant sounds). Acoustic stimulus may take theform of spoken words, music, etc. Acoustic stimulus, in some embodimentsmay be provided via smart speakers or other electronic devices such asAlexa® by Amazon®, Google Home®, etc.

As described above, the modular physiologic monitoring system mayoperate in a therapeutic mode, in that stimulation is provided whenrespiration fails. The modular physiologic monitoring system, however,may also operate as or provide a respiratory pacemaker in otherembodiments. In such embodiments, the modular physiologic monitoringsystem has the potential to reduce the frequency of apneic events andpossibly avoid apneic events altogether. A cardiac pacemaker watches fora cardiac action potential, and if such cardiac action potential doesnot happen within an allotted time frame, the cardiac pacemakerinitiates the pacing automatically. A modular physiologic monitoringsystem may provide a respiratory pacemaker to keep a subject breathing,even in the case that the subject stops breathing during a monitoringsession in a similar manner by monitoring breathing and initiatingstimulus if breathing is not regular or otherwise as desired.

In a therapeutic mode, the modular physiologic monitoring system mayapply stimulus in response to detecting events, where the events arebased on certain thresholds meeting the definitions for events. Examplesof events include apneic events and hypopnea events. An apneic event maybe defined as one in which air flow cessation is 10 seconds or longer. Ahypopnea event may be defined as one in which there is reduced air flowfor 10 seconds or longer. It is to be appreciated, however, that theseevent definitions may be altered as desired, and that numerous otherevent types may be defined as described herein. To determine whetherthese events have occurred, the modular physiologic monitoring systemmay measure a number of physiologic parameters of the subject using oneor more sensing devices. Physiologic parameters may contribute todetection of an event based on thresholds, which may be pre-defined orprogrammable. Thresholds may relate to various physiologic parameters,including but not limited to: hemoglobin oxygen saturation (% HbSAT);end tidal CO₂ value; a respirator quotient value; snoring,thoracoabdominal paradoxic breathing or increased respiratory effort;EEG evidence of disturbance (e.g., Alpha intrusion, epileptiformactivity, etc.); blood pressure criteria; parasomnias (e.g., sleeptalking, sleep walking, bruxism, etc.); flattening of inspiratory nasalflow; apnea-hypopnea index; exceeding preset hypoxemic burden (e.g.,cumulative percentage of time under 90% saturation); rapid eye movement(REM) sleep latency values; lack of physical activity; onset ventricularor atrial ectopy (e.g., bradycardia, tachycardia, arrhythmia such asatrial fibrillation, etc.); and time delay from the last breath,measured by a clock or other means. It is to be appreciated thatembodiments may utilize any one of or combination of these and otherthresholds described herein.

In a prophylactic mode, the modular physiologic monitoring system mayapply stimulus continuously or at defined intervals, rather than (or inaddition to) in response to detecting particular events. Regularstimulation may be provided via one or more stimulating devices so as toestablish a regular breathing cycle. Prophylactic respiratorystimulation provides advantages for neural entrainment/neuroplasticityin keeping breathing constant and continuous. The stimulation may beprovided regularly or at intervals, or with cyclic variation forphysiologic matching (e.g., to match physiologic parameters or activitymeasured by sensing devices in a modular physiologic monitoring system).The stimulation, in some embodiments, may thus be continuous ornear-continuous. Prophylactic respiratory stimulation de-emphasizespathologic components of obstructive sleep apnea (OSA) and otherdiseases of respiration/drive.

Modular physiologic monitoring systems may also provide intermittentstimulation so as to avert or break an apneic event, or pace respirationof a subject in a less continuous method. In such applications, thestimulation may be provided on an as needed basis. Alternatively, thestimulation may be applied in a non-periodic way, so as to break arespiratory cycle, reset a breathing cycle, or the like. The timing ofsuch intermittent stimulation may be influenced by one or more signalsobtained by a sensing device in accordance with the present disclosure.

In some embodiments, modular physiologic monitoring systems may beutilized to provide preventative stimulus, such as providing stimulus ina pulse train with the goal of entrainment or programmingneuroplasticity (e.g., central, peripheral) for normalizing or improvingbreathing in any sleep stage. While awake or under hypnosis, a specificstimulus may be associated with the need to take an unobstructed breath.Using the stimulating devices in the modular physiologic monitoringsystem, such stimulus may be applied. The stimulus may be applied duringconsciousness and/or during sleep. For example, stimulus may be appliedwhile a subject is conscious for learning and teaching, with learningspillover from conscious learned behavior to the sleep state of thesubject. The desired action (e.g., taking an unobstructed breath)becomes a learned reflex for application to the subject via thestimulating devices while the subject is asleep. Hypnosis, meditation orother teaching techniques may be used to facilitate the spillover fromconscious learned behavior to the sleep state of the subject. In someembodiments, a goal is to teach the subject to take unobstructed breathsin response to the associated stimulus.

In some embodiments, stimulus may be provided using voice recordings.For example, the modular physiologic monitoring system may provide thestimulus via an audible command to the subject to perform an actionwhile they are sleeping (e.g., taking an unobstructed breath, movinginto a different position, etc.). In order to make the subject more opento suggestion, the modular physiologic monitoring system may allow thesubject to individualize the commands to suit their preference, such asin allowing the subject to make an audio recording of his/her own voiceor of a trusted voice (e.g., a spouse, parent, etc.). As one example,the subject may be prompted to record “BREATH <subject's name>”, givingfamiliarity to the subject for the auditory stimulus. The auditorystimulus may be provided via an earpiece, a smart speaker, home audiosystem, alarm clock, smart phone, etc. The audible stimulus may also beutilized to facilitate or provide hypnosis.

In some embodiments, a modular physiologic monitoring system may beconfigured to provide multi-modal stimuli to a subject. Multi-modalapproaches use one or more forms of stimulation (e.g., thermal andelectrical, mechanical and electrical, etc.) in order to mimic anotherstimulus to trick local nerves into responding in the same manner to themimicked stimulus. In addition, in some embodiments multi-modal stimulusor input may be used to enhance a particular stimulus. For example, theeffect of a thermal stimulus may be enhanced by adding a mimickedelectrical stimulus.

Modular physiologic monitoring systems may use pulses across space andtime (e.g., frequency, pulse trains, relative amplitudes, etc.) to mimicvibration, comfort or discomfort, mild or greater pain, wet sensation,heat/cold, training neuroplasticity, taste (e.g., using a stimulatingdevice placed in the mouth or on the tongue of a subject to mimic sour,sweet, salt, bitter or umami flavor), tension or stretching, sound oracoustics, sharp or dull pressure, light polarization (e.g., linearversus polar, the “Haidinger Brush”), light color or brightness, etc.

Stimulus amplification may also be provided by modular physiologicmonitoring systems using multi-modal input. Stimulus amplificationrepresents a hybrid approach, wherein a first type of stimulus may beapplied and a second, different type of stimulus provided to enhance theeffect of the first type of stimulus. As an example, a first stimulusmay be provided via a heating element, where the heating element isaugmented by nearby electrodes or other stimulating devices that amplifyand augment the heating stimulus using electrical mimicry in a pacingpattern. Electrical stimulus may also be used as a supplement or tomimic various other types of stimulus, including but not limited tovibration, heat, cold, etc. Different, possibly unique, stimulationpatterns may be applied to the subject, with the central nervous system(CNS) and peripheral nervous system (PNS) interpreting such different orunique stimulation patterns as different stimulus modalities.

Another example of stimulus augmentation is sensing a “real”stimulus,measuring the stimulus, and constructing a proportional response bymimicry such as using electric pulsation. The real stimulus, such assensing heat or cold from a Peltier device, may be measured byelectrical-thermal conversion. This real stimulus may then be amplifiedusing virtual mimicry, which may provide energy savings and thepossibility of modifying virtual stimulus to modify the perception ofthe real stimulus.

In some embodiments, the stimulating devices in a modular physiologicmonitoring system include an electrode array that attaches (e.g., via anadhesive or which is otherwise held in place) to a preferred body part,such as the sole of a foot, the head or forehead, an inner wrist, etc.One or more of the stimulating devices may include a multiplicity ofboth sensing and stimulation electrodes, including different types ofsensing and/or stimulation electrodes. The sensing electrodes on thestimulation devices, in some embodiments, may be distinct from thesensing devices in the modular physiologic monitoring system in that thesensing devices in the modular physiologic monitoring system may be usedto measure physiologic parameters of the subject while the sensingelectrodes on the stimulation devices in the modular physiologicmonitoring system may be utilized to monitor the application of astimulus to the subject.

A test stimulus may be initiated in a pattern in the electrode array,starting from application via one or a few of the stimulation electrodesand increasing in number over time to cover an entire or larger portionof the electrode array. The test stimulus may be used to determine thesubject's response to the applied stimulation. Sensing electrodes on thestimulation devices may be used to monitor the application of thestimulus. The electrode array may also be used to record from desiredoutput (e.g., initiate a breath). As such, one or more of the electrodesin the array may be configured so as to measure the local evokedresponse associated with the stimulus itself. Such an approach may beadvantageous to confirm capture of the target nerves during use. Bymonitoring the neural response to the stimulus, the stimulus parametersincluding amplitude, duration, pulse number, etc. may be adjusted whileensuring that the target nerves are enlisted by the stimulus in use.

The test stimulus may migrate or be applied in a pattern to differentelectrodes at different locations in the electrode array. The responseto the stimulus may be recorded or otherwise measured, using the sensingdevices in the modular physiologic monitoring system and/or one or moreof the sensing electrodes of the stimulating devices in the modularphysiologic monitoring system. The response to the test stimulus may berecorded or analyzed to determine an optimal sensing or application sitefor the stimulus to achieve a desired effect or response in the subject.Thus, the test stimulus may be utilized to find optimal sensing (e.g.,dermatome driver) location. This allows for powerful localization foroptimal pacing or other application of stimulus, which mayindividualized for different subjects.

An electrode array provided by the stimulating devices in the modularphysiologic monitoring system may include an electrode patch that isdriven by another, possibly larger, device that is apposed to the patch.For example, for foot stimulation, the device may be an orthotic. Thepatch may be attached to the skin of the subject, possibly to the soleof a foot of the subject via a biologic adhesive. An orthotic may beattached to the patch via adhesive, magnetic, mechanical snap, acombination thereof, or other attachment means. The orthotic permitsmovement of the device as the physiologic source disappears. As sensingpatterns are completed, areas which are optimal for stimulatingbreathing or another desired result (e.g., optimizing blood pressure(BP) parameters, etc.) may be identified and recorded. Such optimalareas can be used as the principal sites for subsequent stimulation.Over time, the optimal sites may change. Test stimulus may beperiodically re-applied to adjust the optimal sites as desired. With amultiple electrode array, adjustments may be made for optimal sensingand stimulation via algorithmic changes in software, using the samehardware as the electrode array can permit a wide distribution ofelectrodes over a region of the subject. The orthotic may contain apower source, one or more processors, signal processing circuitry, oneor more analog to digital converters, communications circuitry, etc.

A modular physiologic monitoring system which utilizes an electrodearray in stimulating devices has a wide variety of potentialapplications. One such application, in treating OSA, is described above.Other non-limiting examples of potential applications are discussedbelow.

For epilepsy, the modular physiologic monitoring system may include oneor more sensing devices configured to monitor brain activity. Forexample, if a sensing EEG records suspicious activity, the stimulatingdevices in the modular physiologic monitoring system can initiatetherapeutic stimulus. Detected incidents may be used as sources forintervention, such as an algorithm for sensing, locating, processing,amplifying and acting to close the loop. Alternatively or additionally,a baseline stimulation level may be applied to keep desired patterns ofbreathing dominant. For epilepsy, the stimulus may sync with EEG,EOM/EMG of EOM musculature, HR, HRV, or the like. EMG may be used aloneor as one of several inputs. The baseline stimulation may be used as apreventative measure to maintain desired BP characteristics, stable HRrhythms, to avoid or reduce seizures, etc. A normal or desired patternmay be maintained via entrainment and abnormal activity may besuppressed. The gain is as described above with respect to OSA, where asmall geographic stimulus may be amplified by stimulus from surroundingelectrodes, including multi-modal stimulus. The stimulus may be drivenby sensing an initial physiologic response to the small geographicstimulus. The modular physiologic monitoring system may also be used tofind optimal stimulus sites, such as those of acupuncture, reflexologyor other dermal stimulation that moderates and/or modulates hypertension(HTN), HR or other autonomic functions. Several stimulation sites mayalso be used in parallel with one another via timed or synchronizedstimulation, such as via stimulation sites on the head/forehead of thesubject, soles of the feet of the subject, wrist of the subject, etc.

A number of combinations of sensing devices and stimulating deviceswhich may be used in some embodiments will now be described. It is to beappreciated, however, that these combinations are provided by way ofexample only, and that embodiments are not limited to the specificcombinations of sensing and/or stimulating devices described below.

In a first example, a sensing device is placed on the torso of thesubject near enough to the esophagus so as to monitor both an ECG and tolisten to internal lung/esophagus audible noises. The sensing device mayalso be configured to monitor skin temperature as well as to predictcore temperature, to monitor movement and to monitor external audiblesounds (e.g., such as sounds related to speech, snoring, etc.).

In a second example, a first sensing device is placed on the lower backof the subject near to one or more muscle groups so as to measure one ormore EMG signals from local muscles. The first sensing device may alsobe configured to monitor one or more orientation parameters (e.g., tomeasure an orientation of the first sensing device with respect togravity, with respect to a second sensing device or one or more otherdevices placed on or near the subject, etc.). The second sensing deviceis placed on the neck, torso, face, etc. of the subject, configured tomeasure a range of physiological signals as well as the one or moreorientation parameters (e.g., to measure an orientation of the secondsensing device with respect to gravity, with respect to the firstsensing device or one or more other devices placed on or near thesubject, etc.). One or more algorithms are used to collect orientationparameters from the first sensing device and the second sensing deviceto determine the orientation between the first sensing device and thesecond sensing device.

In a third example, a sensing device is placed on the neck of a subject,where the sensing device includes at least one set of electrodes coupledto the neck of the subject as well as a down-facing microphone and/orother acoustic sensor. The sensing device may include an additionaloutfacing microphone. The set of electrodes are configured to measure atleast one EMG signal from the neck of the subject (e.g., musclesassociated with tongue movement, with throat muscle activity, etc.). Theset of electrodes may also include one or more electrodes that areoriented so as to measure an ECG of the subject (e.g., so as to pick-upcardiographic information possibly using the same electrodes thatmeasure the EMG signal). The down-facing microphone or other acousticsensor is configured to monitor for occlusion of the esophagus of thesubject, and to listen for airway sounds of the subject. Optionally, theoutfacing microphone may be configured to monitor audible snoring,choking, and other sounds associated with the airway of the subject.Collectively, the set of electrodes and the down-facing microphone orother acoustic sensor are used to determine if the subject isexperiencing an airway obstruction, has stopped breathing, etc.

In a fourth example, a sensing device is placed on a location of thesubject (e.g., on the skin of the subject). The sensing device includesone or more stretch and/or interfacial pressure sensors, such that thesensing device is configured to measure one or more of pressureapplication and tissue stretch locally at the site of application of thesensing device. A stimulating device is optionally placed onto anothersite on the subject, or at a site on the body of a caregiver, with thestimulating device being configured to apply a stimulus to the subjectbased upon one or more signals measured by the sensing device. Thestimulating device may also or alternatively be configured to provideone or more alerts to the subject and/or caregiver based on the signalsmeasured by the sensing device.

In a fifth example, a stimulating device is placed on a target site on asubject (e.g., sole of the foot, genitals, peroneal tissue, ear, outerear, mastoid region, palm of hand, temple, forehead, jaw, neck, etc.).The stimulating device is configured to provide one or more stimuli(e.g., electrical stimulus, thermal stimulus, vibrational stimulus,stretch action, pinch action, combinations thereof, etc.) to thesubject. The stimulating device may take on a number of form factors,such as a patch-module or patch/hub pair, an adhesively applied device,a sock, an insole, a sandal or shoe, etc., a glove, a wrap (e.g., on afoot, hand, wrist, ankle, genital, etc.), a ring, an earbud or earphonewhich optionally access the mastoid region as a site for stimulus input,a face cover for audio and/or visual stimulus input, a non-contactingstimulating device such as an audio and/or visual system, a systemintegrated into a bed, chair, exercise equipment, etc. Possibleimplementations of these and other form factors are described below.

A stimulating device applied to the subject via an adhesive (e.g., anadhesively applied stimulating device), may be in the form of adisposable or reusable unit, such as a patch and or patch-module orpatch/hub pair as described above with respect to FIG. 1. An adhesivelyapplied stimulating device, in some embodiments, includes a disposableinterface configured so as to be thin, stretchable, able to conform tothe skin of the subject, and sufficiently soft for comfortable wear. Thedisposable interface may be built from very thin, stretchable and/orbreathable materials, such that the subject generally does not feel thedevice on his or her body.

The adhesively applied stimulating device also includes a means forinterfacing with the subject through an adhesive interface and/or awindow in the adhesive interface. Such means may include a plurality ofelectrodes that are coupled with a reusable component of the adhesivelyapplied stimulating device and that are coupled to the body of thesubject through the adhesive interface. The means may also oralternatively include: a vibrating actuator to provide vibration normalto and/or transverse to the surface of the skin on which the adhesivelyapplied stimulating device is attached to the subject; a thermal devicesuch as a Peltier device, a heating element, a cooling element, an RFheating circuit, an ultrasound source, etc.; a means for stroking theskin such as a shape memory actuator, an electroactive polymer actuator,etc.; a means for applying pressure to the skin such as a pneumaticactuator, a hydraulic actuator, etc.

Actuation means of the adhesively applied stimulating device may beapplied over a small region of the applied area of the subject, suchthat the adhesive interface provides the biasing force necessary tocounter the actuation of the actuation means against the skin of thesubject.

Adhesively applied stimulating devices may be provided as twocomponents—a disposable body interface and a reusable component. Thedisposable body interface may be applied so as to conform to the desiredanatomy of the subject, and wrap around the body such that the reusablecomponent may interface with the disposable component in a region thatis open and free from a natural interface between the subject andanother surface. As an example, the disposable body interface mayinclude a thin, breathable and disposable element including a pluralityof electrodes that is applied over the base of a foot of a subject suchthat the plurality of electrodes are biased against the medial plantar,lateral plantar, saphenous, tibial, and/or sural dermatomes of the foot,with one or more regions of the disposable body interface extendingaround from the plantar to the dorsal surface of the foot or to theankle. Over the region of the patch on the dorsal surface or ankleregion, the reusable component such as a module or hub may be appliedsuch that the electrode interface, power, etc. may be provided by asealed, reusable device through the disposable interface. By locatingthe device attachment region on the dorsal region of the foot or nearthe ankle, a more repeatable attachment location may be achieved.

An adhesively applied stimulating device may also be a single component,rather than a two component or other multi-component arrangement. Such adevice implemented as a single component may include an adhesiveinterface to the subject including two or more electrodes that isapplied to the subject. Adhesively applied stimulating devices embodiedas a single component provide potential advantages such as easierapplication to the body of the subject, but may come at a disadvantagewith regards to one or more of breathability, conformity, access tochallenging interfaces, etc. relative to two component ormulti-component arrangements.

FIG. 2 illustrates an example of an adhesively applied stimulatingdevice embodied as a patch-module pair 200. As shown, the patch-modulepair 200, including module 205 coupled to patch 210, is applied to askin surface 202 of a subject 201. It is to be appreciated that thepatch-module pair 200 may function as a sensing device in addition to orinstead of a stimulating device depending on the functionality of theelectrodes 215 a, 215 b, 220 a, 220 b included in the patch 210.Electrodes 215 a, 215 b are outwardly facing (e.g., away from the skinsurface 202 of the subject 201). Electrodes 220 a, 220 b interface withthe skin surface 202 of the subject 201. One or more of the electrodes215 a, 215 b, 220 a, 220 b may be used as sensors to sense physiologicparameters associated with the subject 201 and/or the ambientenvironment around the subject 201. One or more of the electrodes mayalso or alternatively be configured to apply stimuli to the subject 201.

The patch-module pair 200 is in wireless communication 250 with one ormore other devices in a modular physiologic monitoring system, such asone or more other stimulating devices, one or more sensing devicesand/or a host device. Advantageously, patch 210 may be stretchy so as tomaintain monitoring and/or application of stimuli to the subject 201 inlight of movements, changes in shape or stretching along the skinsurface 202 of the subject 201. The patch-module pair 200 is an exampleof a multi-component adhesively applied device, in that the patch-modulepair 200 includes a low cost disposable patch 210 and a miniaturereusable module 205. Such a configuration may be advantageous to providea soft and comfortable sensing and/or stimulating device for a modularphysiologic monitoring system.

As discussed above, various types of input or stimulus may be applied toa subject with a stimulating device. In some embodiments, the stimulusis in the form of electrical shock. For example, the skin-interfacingelectrodes 220 a, 220 b of patch 210 may be configured to applyelectrical energy to the subject 201. FIGS. 3-5 show examples ofadhesively applied stimulating devices which utilize other means forapplying other types of stimulus.

FIG. 3 illustrates a patch-module pair 300 configured to applyvibrational energy or stimulus 325 to the skin surface 302 of subject301. The patch-module pair 300 includes an adhesive layer 310 (e.g.,potentially forming part of a patch) and a module 315. The adhesivelayer 310 secures the patch-module pair 300 to the skin surface 302 ofthe subject 301. The module 315 includes a transducer 305 configured togenerate vibrational energy 325 for transfer 330 into the subject 301.The transducer 305 may be controlled and/or powered by an electronicsunit 320 included in the module 315. In the non-limiting example shown,the transducer 305 may be piezoelectric material (e.g., a polymer,ceramic, etc.).

FIG. 4 illustrates a patch-module pair 400 for applying thermal energyor stimulus 430 to a subject 401. The patch-module pair 400 includes anadhesive layer 410 (e.g., potentially forming part of a patch) and amodule 415. The adhesive layer 410 secures the patch-module pair 400 tothe skin surface 402 of the subject 401. The module 415 includes one ormore heater bands 405 or RF heating circuits, and thermocouples 406coupled to an electronics unit 420 including a power source, amicrocircuit, etc. via one or more electronic interconnects 408.

FIG. 5 illustrates a patch-module pair 500 for applying a tactile inputor stimulus 525 to a subject 501. The patch-module pair 500 includes anadhesive layer 510 (e.g., potentially forming part of a patch) and amodule 515. The adhesive layer 510 secures the patch-module pair 500 tothe skin surface 502 of the subject 501. The module 515 includes atransducer 505 configured to generate torsional energy 525 for transfer530, 535, 540 into the subject 501. The transducer 505 may be controlledand/or powered by an electronics unit 520 included in the module 515. Inthe non-limiting example shown, the transducer 505 may be an electricmotor with an eccentricity on the output shaft thereof. The transfer530, 535, 540 of energy into the skin surface 502 of the subject 501 mayinduce a range of sensations (e.g., poking, rubbing, etc.) dependentupon the amplitude, frequency, duration, duty cycle, etc. of thetransducer 505 as well as the physical configuration of the patch-modulepair 500 and the choice of adhesive layer 510, if such a layer is usedin the embodiment in question.

It is to be appreciated that the means described with respect to FIGS.2-5 for applying stimulus to a subject are not limited to use solely instimulating devices which utilize an adhesively applied form factor.Similar means may be utilized in other form factors described below.

For the sock form factor, the stimulating device or a disposablecomponent thereof may be integrated into a sock. The sock may includeone or more electrodes (e.g., dry electrodes, wet electrodes, electrodeswith adhesives and/or slick gel-like interfaces, etc.) and one or moreleads connecting the electrodes with a coupling region located elsewhereon the sock. A reusable component of the stimulating device, such as amodule or hub, may interface with the coupling region to provideelectrical or other stimuli to the subject through the one or moreelectrodes.

In some embodiments, stimulus is focused for application to the foot ofa subject. Sock-based approaches for stimulating devices for example,can be used to provide an interface with the bottom of the foot toprovide stimuli to the subject. Specifically, a sock-based stimulatingdevice may apply stimuli to the plantar region on the foot of a subject.

A sock-based stimulating device may include fabric that is formed into agenerally tube-like structure so as to conform to feature(s) of a footwhen pulled thereon. The sock may include a plurality of electrodes,facing towards an interior thereof. One or more of these electrodes mayinclude an ionically conducting gel medium for providing electricalcommunication with the tissues of a subject when biased towards thetissues thereof. The sock may include a plurality of electricalinterconnects and a coupling region, with the interconnects providingelectrical connections between features in the coupling region and theelectrodes. The coupling region is arranged so as to receive a module,with the module electrically coupling to the electrodes via the featuresin the coupling region upon connection to the sock. The module isconfigured so as to deliver one or more electrical signals to thesubject via one or more of the electrodes based upon a signal receivedfrom a monitoring means, such as the sensing devices or a host devicecoupled to the sensing devices.

In some embodiments, stimulus is focused for application to the foot ofa subject. Orthotic-based approaches for stimulating devices forexample, can be used to provide an interface with the bottom of the footto provide stimuli to the subject. Specifically, an orthotic-basedstimulating device may apply stimuli to the plantar region on the footof a subject. The orthotic may be provided with similar size and shapeas an insole, the orthotic including one or more stimulating electrodes,arranged along a surface thereof such that the electrodes are biasedagainst the tissue of the foot during use. The orthotic may be insertedinto a slipper, a sandal, a shoe, or the like. The electrodes may beprovided with a conductive gel applied over the electrode regions so asto electrically interface with the subject during use. Unlike anadhesively applied device, the conductive gel may be slick orrubber-like so as to provide the necessary electrical interface, but notadhere to the adjacent tissues during use.

The sensing devices in a modular physiologic monitoring system, or ahost device in communication with the sensing devices and thestimulating devices, are configured to monitor the state of the subjectand to deliver signals to the stimulating devices in response to themonitoring.

In some embodiments, the signals may be generated by a local sensoryarrangement on a sock-based stimulating device and/or a module attachedthereto so as to determine a local blood oxygen level (e.g., saturationof peripheral oxygen (SpO2)) of the subject, movement of the appendage,or a signal related thereto. The signal may be used to stimulate thesubject related to the monitored SpO2 levels. In some embodiments, alocal assessment of the blood oxygen of the subject is performed withthe module attached to the sock-based stimulating device to determinewhether the levels are found to change from that of a normal person or anormal level determined for a particular subject to a depressed level. Astimulus is then provided to the actuators and/or electrodes in thesock-based stimulating devices to stimulate sensors in the plantarregion of the foot of the subject. Feedback from the sensory input maybe used to determine if the stimulus was effective at correcting theevent.

FIG. 6 illustrates a sock-like stimulating device 600. As shown in thecut-out region 601, a number of electrodes, actuators and/or powermodules 603 may be affixed to an interior surface of the sock 600 so asto interface with the sole of a foot of a subject when the sock 600 isworn by the subject. While FIG. 6 illustrates an arrangement wherein theelectrodes 603 are on the bottom of the interior surface of the sock 600so as to interface with the sole of the foot of a subject, one or moreelectrodes, power modules or other sensing or stimulus means may beplaced elsewhere on the sock, such as on a top of the interior surfaceof the sock 600 so as to interface with a top of the foot rather than orin addition to the sole of the foot when the sock 600 is worn. Unlessotherwise noted, electrodes 603 and other electrodes referred to hereinmay refer to electrically stimulating electrodes or various other typesof stimulating means including but not limited to the means describedabove with respect to FIGS. 3-5. Interconnects 604 couple the electrodes603 to one another and/or to a module 605 attached to a coupling regionof the sock 600.

The stimulating device may be integrated into an insole, a sandal, ashoe, etc., where the stimulating device is attached to the subject withan interface region mounted onto an orthotic, insole, etc. The orthoticor insole may house one or more reusable components or hardware. Thestimulating device or a disposable component thereof is thus easy toattach or remove. The disposable component of the stimulating device maybe easily removed, with the reusable component kept within the orthotic,insole, shoe, etc. for longer term use with the subject. In someembodiments, the orthotic, insole, shoe, etc. is form fitted to theanatomy of a particular subject, the body interface attached there over,and the hardware embedded therein.

FIG. 7 illustrates example arrangements of electrodes or otherstimulating or sensing means which may be integrated into an insole,sandal, a shoe, an orthotic, etc. The electrode arrangements shown mayalso be used for the interior surface of a sock form factor, the wrapform factor or other form factors configured for attachment to the footof a subject. On the left-hand side of FIG. 7, a first electrodearrangement 701 a is illustrated, with a number of smaller electrodes703 a positioned as shown. On the right-hand side of FIG. 7, a secondelectrode arrangement 701 b is illustrated, with a number of largerelectrodes 703 b. The electrodes may be positioned so as to providestimulus or input at defined regions of the foot to providecorresponding effects at various parts or regions of the body. FIGS. 8and 9 illustrate examples of regions of the foot which may be stimulatedto effect corresponding regions of the body of the subject. Althoughshown as distinct, in some embodiments a stimulating device, such as asock, insole, sandal, shoe, etc. may use combinations of electrodes 703a, 703 b shown in the first and second electrode arrangements 701 a, 701b. For example, in some embodiments smaller electrodes 703 a may beinterspersed with larger electrodes 703 b.

Inputs can be provided to cover various areas of the foot, including butnot limited to the toes, heel, areas with dense arrays of electrodes oractuators (e.g., electrode arrangements 701 a, 701 b), etc. In somecases, combinations of the electrodes or actuators 703 a, 703 b may beused to provide multi-modal input or stimulus to the subject, such astemperature and electrical stimulation to amplify the response of one ofthe stimuli with a subject. In some embodiments, stimulus applied viaone or more of the electrodes 703 a, 703 b may be monitored using one ormore sensing devices in a modular physiologic monitoring system, so thatthe system can determine if the stimulus is of the right magnitude orspectrum, if it is generating a desired response, etc.

In the FIG. 7 example, interconnects connecting the electrodes 703 a,703 b may run up the side of the foot to electronics located on the topof the foot or on the ankle. FIG. 10 illustrates such an arrangementincluding a patch 1000 with a reusable module 1002 attached to the patch1000. The patch-based stimulating device shown in FIG. 10 may be used toapply electrical stimuli to the plantar region of the foot of a subjectin response to physiologic information collected from the subject usingone or more sensing devices as described herein. The patch 1000 mayinclude an electrode arrangement, such as electrode arrangements 701 aand/or 701 b, to interact with desired dermatomes on the foot. Thereusable module 1002 can be attached and removed from the patch 1000,and is configured for communication with other devices in a modularphysiologic monitoring system. The module 1002, for example, may receivesignaling from a host device or from one or more sensing devices whichcauses the module 1002 to direct electrodes on the patch 1000 to applystimuli to target regions of the foot of the subject.

FIGS. 11a-e illustrate non-limiting examples of patch electrode layouts.

FIG. 11a shows a patch 1101 coupled to a module 1103. The patch 1101includes a plurality of electrodes 1105 a, 1105 b for interfacing with asubject. The electrodes 1105 a, 1105 b are arranged in a very tightbipolar arrangement suitable for obtaining a bipolar electrical readingfrom the surface of a subject with a very small profile. In aspects, oneor more of the electrodes 1105 a,b may include an electrode feature forenhancing the electrical coupling between the module 1103 and theunderlying tissues of a subject. In aspects, pressure applied to the topof an attached module 1103 may be suitable for engaging such anelectrode feature with the underlying tissue of the subject. Such anarrangement may be advantageous for providing an ultra-miniatureheart-rate monitor, a pediatric heart-rate monitor, an EMG sensor forplacement near a sexual organ, an electrophysiological monitor behind anear, on a neck, etc., and/or to provide a stimulating device asdescribed herein.

FIG. 11b shows a patch 1107 coupled to a module 1109. The patch 1107includes a bipolar electrode arrangement 1111 a, 1111 b for interfacingwith a subject. Such an arrangement may be advantageous for monitoringheart-rate, a signal channel EKG, respiration rate, etc. of a subject aspart of a monitoring session, and/or to provide a stimulating device asdescribed herein. A plurality of such patches 1107 may be applied to asubject to simultaneously extract a higher level or spatiallydistributed electrical field over the body of the subject.

FIG. 11c shows a patch 1113 coupled to a module 1115. The patch 1113includes three electrodes 1117 a, 1117 b, 1117 c for interfacing with asubject. The electrodes 1117 a, 1117 b, 1117 c may be arranged so as toallow for multi-site capture of electrophysiological activity on thesubject. Such an arrangement may be advantageous for generating a fieldvector in the vicinity of the patch 1113, and/or for applying a stimulusto the subject.

FIG. 11d shows a patch 1119 coupled to a module 1121 each in accordancewith the present disclosure. The patch 1119 includes a quadripolarelectrode arrangement 1123 a, 1123 b, 11123 c, 1123 d for interfacingwith a subject. The quadripolar electrodes 1123 a, 1123 b, 1123 c, 1123d may be arranged so as to allow for multi-site capture ofelectrophysiological activity on the subject, and/or for applyingstimuli to the subject. Such an arrangement may be advantageous forgenerating a field vector in the vicinity of the patch 1119, for mappingelectric field propagation across the surface of the subject, etc.

FIG. 11e shows a patch 1125 coupled to a module 1127 each in accordancewith the present disclosure. The patch 1125 includes a plurality ofelectrodes 1129 a, 1129 b for interfacing with a subject. The electrodes1129 a, 1129 b are shown in a bipolar arrangement connected tostretchable conducting elements 1131 a, 1132 b. In aspects, such aconfiguration may be advantageous to freely flex and stretch 1133 alongwith the nearby tissues of the subject during a monitoring and/orstimulating session. The stretchable conducting elements 1131 a, 1131 bmay be arranged so as to repeatably change impedance during stretch.Such a configuration may be advantageous for assessing movement underthe patch (e.g., due to muscle movement, breathing, etc.) in conjunctionwith one or more physiologic signals (e.g., such as electrophysiologicalsignals, stretch related artifact, etc.) in accordance with the presentdisclosure. Such a configuration may be suitable for physiotherapymonitoring sessions (e.g., combined proprioceptive monitoring inconjunction with EMG, assessing breathing in conjunction with EKG, gaitassessment, a running gait correction system, etc.).

FIG. 12a shows a patch-module pair 1200 including a patch 1241 coupledto a module 1243. The patch 1241 is substantially rectangular, andsuited for attachment to the foot of a subject. The patch 1241 includesa number of sensing electrodes 1245 and a number of stimulatingelectrodes 1247. The module 1243 includes various electronics, includingbut not limited to a battery. Each of the electrodes 1245, 1247 may bemonopolar, bipolar or multipolar as desired.

FIG. 12b shows a side view of the patch-module pair 1200, illustratingthat the electrodes 1245, 1247 and an adhesive 1249 are on a first sideof the patch 1241 while the electronics of module 1243 are on anopposite side of the patch 1241. It is to be appreciated, however, thatin some embodiments electronics such as module 1243 may be on the sameside of a patch as electrodes 1245, 1247.

FIG. 12c shows the patch-module pair 1200 applied to the sole of a footof a subject 1201. FIG. 12c shows the patch-module pair 1200 before andafter attachment to the sole of the foot of the subject 1201.

In a glove form factor, the stimulating device may be integrated intothe glove such that stimulus is provided to a region of the palm of thehand on which the glove is worn or to a wrist, a finger or the like. Theglove may include one or more stimulus generating components (e.g.,thermomechanical devices, electrodes, etc.) coupled with one or moreother hardware components. In some embodiments, a flexible interface maybe incorporated into the glove so as to provide the interface along withcoupling elements to couple the interface with reusable hardwarecomponents.

FIG. 13 illustrates a glove-like stimulating device 1300. As shown inthe cut-out region 1301, a number of electrodes and/or power modules1303 may be affixed to an interior surface of the glove 1300 so as tointerface with the palm of a hand of a subject when the glove 1300 isworn by the subject. It is to be appreciated that electrodes 1303 may beplaced as desired within the glove 1300, so as to interface with one ormore fingers of the subject when the glove 1300 is worn, the back of thehand of the subject when the glove 1300 is worn, etc. in addition to orin place of electrodes configured to interface with the palm of the handof the subject. Interconnects 1304 couple the electrodes 1303 to oneanother and/or to a module 1305 attached to the glove 1300.

The stimulating device may also take the form of a wrap, as opposed to asock, glove sandal, etc. The wrap may be configured for application tovarious regions of the body of the subject, including but not limited tothe feet, hands, wrists, ankles, genitals, etc. The wrap may beconfigured with a region having one or more stimulating elements (e.g.,electrodes, etc.) oriented such that, when wrapped around the targetanatomy, the stimulating elements interface with target tissues. Thewrap may include stretchable conducting interconnects coupling thestimulating elements to reusable hardware elements or components. Thewrap may be single-use disposable or multiple-use disposable, while thehardware may be reused indefinitely.

A stimulating device may be provided as an earbud or earphone,optionally with access to the mastoid region as a site for input ofstimulus to the subject. Such a device may include one or more means forproviding audible stimuli to the subject. The device may also oralternatively include one or more actuators for orientation along theear canal and/or along the mastoid region so as to provide vibrationaland/or mechanical stroking type input or stimulus to the subject alongkey dermatomes.

FIG. 14 illustrates stimulating and sensing devices in the form of wrap1400 and earbud 1450. The wrap 1400 provides an impact sensing patchintegrated into a knee brace on a subject 1401. The wrap 1400 mayinclude one or more piezoresistive materials (e.g., materials thatchange electrical properties or charge storage thereupon in relation tostrains placed thereupon), a capacitive stretch sensor, a pressuresensitive nano-composite structure, or the like. Upon impact 1403 of thewrap 1400 with an object 1402, a coupled module 1410 may send one ormore signals 1415 to earbud 1450, a host device, etc.

The earbud 1450 is attached to the ear 1451 of the subject or to anotherindividual associated with the subject such as a caregiver. The earbudmay receive signaling 1460 (e.g., directly from wrap 1400, one or moreother sensing devices, a host device, etc.) and produce a feedbacksignal or other input or stimulus (e.g., an audio signal, a vibrationsignal, a tactile signal, a visual signal, etc.) for delivery to thesubject. In the FIG. 14 example, the earbud 1450 produces audiblefeedback or stimulus to the ear 1451 via a loudspeaker 1455.

The combination of wrap 1400 and earbud 1450 may be advantageous formonitoring impacts on a subject with neuropathy (e.g., lack of sensationin an extremity, for assistance with gait analysis, for providingfeedback during exercise, etc.) and providing feedback or stimulus inresponse thereto, such as by providing the subject with a transferredsensation of touch in a region of their body that still has sensation(e.g., via a tactile feedback component, audible cue, visual cue, etc.),or for formation of a feedback loop to a touch related event.

The wrap 1400 can measure interfacial pressure information and provideit to the earbud 1450 or another stimulating device. As mentioned above,such an arrangement is useful for helping a subject feel in a region ofthe body that has no feeling, assisting with recovery of feeling in aregion during physiotherapy, etc. Although FIG. 14 illustrates anexample wherein the wrap 1400 acts as a sensing device, in otherembodiments wrap-like devices may function as stimulating devices. Inaddition, the use of earbud 1450 as a stimulating device is presented byway of example only, and a wide variety of other types of stimulatingdevices may be used in conjunction with wrap 1400 as described herein.

For a ring or band form factor, the ring or band may be applied to oneor more fingers, toes, genitals, wrist or the like so as to interfacewith nerves in the vicinity thereof. The ring or band may include aplurality of electrodes on the underside thereof, one or more vibratingelements, one or more thermal elements or other stimulating hardwarecomponents. The ring or band may include additional hardware componentsto wirelessly receive signals from an external device, the externaldevice generating the signals to apply stimulus to the subject throughthe interface via the electrodes, vibrating elements, thermal elementsor other stimulating hardware components.

FIG. 15 illustrates a ring- or band-like stimulating device 1500. Asshown, the ring 1500 includes a number of electrodes 1501 on an interiorsurface thereof, configured to interface with the skin of a subject whenthe ring 1500 is worn. Although not explicitly shown, the electrodes1501 may be coupled to one another and/or to a module configured forattachment to or communication with the ring 1500.

A face cover may provide a form factor for audio and/or visual input tothe subject. The face cover may be, for example a wearable sleep maskwith audio and/or visual means to provide stimuli to the subject duringsleep. The mask may be wirelessly coupled with an external system orhost device, with the external system providing signals to directstimulation by the audio and/or visual means of the mask. In aspects,the mask or other face cover may include one or more sensors forinterfacing with the subject to provide for monitoring of EEG, EOG,facial EMG, or the like, in combination with the ability to providestimuli to the subject when an event occurs.

FIG. 16 illustrates a face cover stimulating device in the form of asleep mask 1600. As shown, the sleep mask 1600 includes a number ofelements 1601 on an interior surface thereof, such that when the sleepmask 1600 is worn by a subject the elements 1601 may provide a stimulus(e.g., an audible stimulus, a visual stimulus, etc.) to the subject. Theelements 1601 may be speakers, light-emitting devices such aslight-emitting diodes (LEDs), etc. In some embodiments, the elements1601 may represent pixels on a video screen for displaying images to thesubject. A module 1605 is shown attached to the face cover 1600. Themodule 1605 may be coupled to one or more of the elements 1601.

A non-contacting stimulating device may be, for example and audio and/orvisual system, a heating or cooling system, etc. Smart speakers andsmart televisions or other displays are examples of audio and/or visualnon-contacting stimulation devices. A smart speaker, for example, may beused to provide audible stimulus to the subject in the form of an alert,a suggestion, a command, music, other sounds, etc. Other examples ofnon-contacting stimulation devices include means for controllingtemperature such as fans, air conditioners, heaters, etc.

One or more stimulating devices may also be incorporated in othersystems, such as stimulating devices integrated into a bed, chair,operating table, exercise equipment, etc. that a subject interfaceswith. A bed, for example, may include one or more pneumatic actuators,vibration actuators, shakers, or the like to provide a stimulus to thesubject in response to a command, feedback signal or control signalgenerated based on measurement of one or more physiologic parameters ofthe subject utilizing one or more sensing devices.

Although the disclosure has discussed devices attached to the body formonitoring aspects of the subject's disorder and/or physiologicinformation, as well as providing a stimulus, therapeutic stimulus, etc.alternative devices may be considered. Non-contacting devices may beused to obtain movement information, audible information (such assnoring), skin blood flow changes (e.g., such as by monitoring subtleskin tone changes which correlate with heart rate), respiration (e.g.,audible sounds and movement related to respiration), and the like. Suchnon-contacting devices may be used to supplement an on-body system orfor the monitoring of certain conditions (e.g., such as snoring, anobvious apneic event, etc.) be a source of alert or event information,stimulus, etc. Information captured by non-contacting devices may, onits own or in combination with information gathered from sensing deviceson the body, be used to direct the application of stimulus to thesubject, via one or more stimulating devices on the body and/or via oneor more non-contacting stimulating devices.

In some embodiments, aspects of monitoring the subject utilizing sensingdevices in the modular physiologic monitoring system may utilize sensingdevices that are affixed to or embodied within one or more contactsurfaces, such as surfaces on a piece of furniture on which a subject ispositioned (e.g., the surface of a bed, a recliner, a car seat, etc.).The surface may be equipped with one or more sensors to monitor themovement, respiration, HR, etc. of the subject. To achieve reliablerecordings, it as advantageous to have such surfaces be well positionedagainst the subject. It is also advantageous to build such surfaces totake into account comfort level of the subject to keep the subject fromfeeling the sensing surfaces and to maintain use of the sensing surfaceover time.

Stimulating devices, as discussed above, may take the form of audio,visual or audiovisual systems or devices in the sleep space of thesubject. Examples of such stimulating devices include smart speakers.Such stimulating devices provide a means for instruction a subject toalter the sleep state thereof. The input or stimulus may take the formof a message, suggestion, command, audible alert, musical input, changein musical input, a visual alert, one or more lights, a combination oflight and sound, etc. Examples of such non-contacting stimulatingdevices include systems such as Amazon Echo®, Google Home® and the like.

FIG. 17 illustrates a stimulating device incorporated into a bed 1700,along with a number of non-contacting stimulating devices such as aspeaker 1705, a heating and cooling system 1710 and a display 1715. Thebed 1700 includes one or more electrodes 1701. As shown, the electrodes1701 are configured to interface with a back of the subject while thesubject lies on the bed 1700. The non-contacting stimulating devices maybe arranged so as to provide stimuli to the subject while the subject islying on the bed. For example, the speaker 1705 may be placed as desiredto provide audible stimulus. The heating and cooling system 1710 maytake the form of a general air conditioning unit in a room in which thebed 1700 is placed, a heater in the room in which the bed is placed, avent or fan in the room configured to blow cool or hot air at one ormore desired areas of the bed 1700, etc. The display 1715 may take theform of a television, projector, etc. positioned so as to be viewed bythe subject while the subject lays on the bed 1700.

As described above, a modular physiologic monitoring system may includea number of sensing devices which may be utilized to determine postureor relative positioning of different region of the body of a subject.FIG. 18 illustrates various sleep postures, for example. Sensing devicesmay be arranged on the subject, in or on contacting surfaces such as abed of the subject, or on a non-contacting device such as cameras whichcan record images of the subject, etc. Such sensing devices can be usedto determine sleep posture at a macro level (e.g., which side of thebody is “up” or “down”), whether a region of the body is covered oruncovered, etc. The macro sleep posture may be used to assesspositioning of the subject with respect to events detected during sleep.If a sleep event (e.g., an apneic event, snoring, etc.) is postural innature, corrective stimuli can be sent such that when the subject movesinto a different sleep posture, either to avoid a sleep event before ithappens or to correct an ongoing sleep event. Sleep posture may also beadjusted via corrective stimuli to encourage better postures to increasesleep quality, avoid pain (e.g., back pain from sleeping in certainpositions, etc.).

Multiple sensing devices in a modular physiologic monitoring system mayalso be used to obtain information relating to the relative orientationor positioning of different regions or parts of the body of a subject.FIG. 19, for example, illustrates two sensing devices 1902 and 1904placed on the neck and lower back of a subject, respectively, as thesubject moves between positions 1900, 1905 and 1910. Informationobtained from the sensors 1902 and 1904 may be used to compare postureof different regions of the body in various ways (e.g., usingorientation vectors with respect to gravity, obtaining inter-deviceorientation information in combination with barometers to determineheight differences between devices in a gravitational field, etc.).Collectively, multiple sensing devices may be utilized to determinespinal alignment, neck alignment, pelvic alignment, etc. during sleep.The sensing devices 1902 and 1904, in some embodiments, may also beconfigured to monitor local EMG to determine local muscle spasms duringmonitoring of a subject in conjunction with posture.

FIG. 20 illustrates an example wherein sensing devices placed on thehead/neck and torso of a subject (not explicitly shown) may be used tomonitor neck alignment of a subject. Positions 2000 and 2005 showexamples of neck misalignment while positions 2010 and 2015 showexamples of proper neck alignment.

A modular physiologic monitoring system may be used to sense physiologicparameters associated with physical exertion. A number of physiologicparameters may be combined or integrated to determine a state ofphysical status of a subject. For example, one or more sensing devicesmay be used to provide levels of heat stress, or information which maybe utilized to derive levels of heat stress, where the levels of heatstress and possibly other parameters are integrated to provide areal-time assessment of the current state of the subject and to measureprogress to a state associated with more or less physical stress. Themodular physiologic monitoring system may provide warnings, eitheranalog or digital (e.g., numbers, colors shapes) as feedback or stimulus(e.g., telemetry including wireless telemetry) to the subject or to aremote monitoring system, physician, caregiver, etc.

To monitor physical exertion, such as body temperature and fatigue, amodular physiologic monitoring system in some embodiments utilizes anadhesive patch with multiple sensing capabilities as the sensingdevice(s). A patch may be configured with several components withdiffering specific heat conduction characteristics. The patch mayinclude or be configured with one or more insulating regions with lowheat transmission, one or more thermally conducting regions, a pluralityof temperature sensors, one or more environmental sensors, combinationsthereof and the like.

An insulating region of the patch is placed over the skin, and isconfigured to limit local heat transfer from the skin to thesurroundings (e.g., to form a local region with warm skin and/or tolimit skin heat loss). The insulating region may cause arteriolar orvascular vasodilation. One or more thermal sensors may be positioned atthe skin site under insulating regions of the patch. Blood temperatureunder the insulating region will be close to the core body temperatureof the subject, and thus permits superficial measurement of core bodytemperature. The insulating region of the patch may also cause sweatingor perspiration of the subject. As sweat is derived from blood, thesweat temperature, if prevented from cooling, can provide a good measureof core body temperature and/or blood temperature.

A thermally conducting region of the patch is placed over the skin, andis configured to allow for maximal heat transfer from the skin to theenvironment. The conducting region will have a strong tendency to remainat a basic skin temperature.

A plurality of temperature sensors may be arranged in the variousinsulating and/or thermally conducting regions of the patch, andconfigured to measure temperature in such regions. The plurality oftemperature sensors may also include one or more sensors arranged alonga vector substantially normal to the skin surface so as to measure athermal gradient there along.

Environmental sensors on the patch may be configured to estimate thermalproperties of the immediate surroundings of the patch. Such thermalproperties include but are not limited to humidity (e.g., measured withan onboard and/or remote sensors), local air temperature, local airvelocity and/or turbidity, a barometer to give local ambient pressurechanges, an immediate light vicinity sensor (e.g., for measurement ofambient light or infrared to a region of the patch), etc.

The patch, a module attached thereto, or a host device in communicationwith the patch and/or module is configured with a thermal differencealgorithm configured to derive thermal gradients from the multipletemperature sensor readings and to make a prediction or estimation ofcore body temperature, heat loss, metabolism, etc. The patch may alsoinclude one or more physiologic sensors, with measurements therefrombeing used to derive parameters such as heat loss, metabolism,efficiency or the like from the subject.

In one embodiment, the system may include a plurality of temperaturesensors, each temperature sensor situated in/on the patch or hub module.Each temperature sensor may be positioned such that it has asubstantially known thermal transfer characteristic with respect to oneor more surfaces of the module and/or the patch. In one embodiment, themodule includes a plurality of temperature sensors, one or more sensorsbeing situated substantially near the top surface of the module (e.g.,the surface that faces outward from the subject and towards thesurrounding environment during use) and one or more temperature sensorsbeing situated substantially near the bottom surface of the module(e.g., the surface that is biased against a patch and/or skin surface ofa subject during use). The temperature readings obtained by the sensorslocated nearest to the skin of the subject are more reflective of theskin temperature of the subject at the site of application to thesubject, while the temperature readings obtained by the sensors locatednearest to the environment of the subject are more reflective of theenvironmental temperature surrounding the location of application of themodule to the subject. Collectively, the temperature readings from theplurality of sensors may be used to determine the skin temperature ofthe subject as well as the local heat loss from the subject during use.

In addition to temperature sensing, one or more humidity sensors, fluidvelocity sensors (e.g., an anemometer, a microelectromechanical system(MEMS) based anemometer, a MEMS hotwire anemometer, etc.), and/orbarometers may be added to the module or the patch so as to increase theenvironmental information obtained during usage. In one non-limitingexample, a humidity sensor may be located in the module near to the topsurface thereof, the humidity sensor used to determine the localhumidity around the module during use, the thermal transfercharacteristic to the surrounding environment determined at least inpart with the assistance of the humidity sensor. In another non-limitingexample, a MEMS based micro-anemometer is placed into the module near tothe upper surface thereof, the local airflow velocity and/or heattransfer characteristics to the surrounding environment in the vicinityof the module determined at least in part with measurements obtainedfrom the micro-anemometer.

In one non-limiting example, a temperature sensor may be integrated intothe patch. The integrated temperature sensor may have a thickness ofless than 0.2 mm, less than 0.1 mm, less than 0.05 mm, or the like. Thesensor may be coupled to one or more conducting traces in the patch, soas to provide an electrical interface thereto. The temperature sensormay be used to determine the temperature and/or heat transfercharacteristic at a site on the subject, substantially removed from thevicinity of the module.

In one non-limiting example, a plurality of temperature sensors may beintegrated into the module and/or patch, and one or more thermallycontrolled features may be added there-over or there-under so as toinfluence a heat transfer characteristic and/or heat capacity in thevicinity thereof. In one non-limiting example, a thermally insulatingmaterial (e.g., a fibrous material, an aerogel, a porous foam material,or the like), or a thermally conducting material (e.g., a metalliccomposite, a thermally conducting ink, a metal foil, or the like), maybe added as the thermally controlled feature. In aspects, the thermallycontrolled feature may be inserted so as to bias the temperature readingobtained by the temperature sensor to be closer to that of the localskin temperature, and in aspects the thermally controlled feature may beinserted so as to bias the temperature reading obtained by thetemperature sensor so as to be closer to that of the surroundings. Inaspects, matched temperature sensors may be placed into the patch inclose vicinity to one another, and one or more thermally controlledfeatures applied such that a differential reading may be obtained fromotherwise calibrated sensors. The differential reading may be used todetermine the local heat flux from the skin of the subject during use.

The thermal transfer characteristics (e.g., the heat transfercharacteristics, the heat capacity, the internal thermal sourcecharacteristics of the module, etc.) may be determined a priori orduring a calibration procedure. The heat transfer through the module maybe determined by the temperature differences of the temperature sensorslocated near to the top surface and near to the bottom surface of thedevice.

In some usage scenarios, one or more current sensors in the device maybe used to determine the extent of one or more thermal sources withinthe module and/or patch of the subject. In one non-limiting example, thethermal sources may include inefficiency in the battery, the powermanagement circuitry, the radio, and one or more components in thedevice. In aspects, a thermal source map may be generated a priori fromthe layout and power consumption information (e.g., power consumptiondetermined by one or more current readings), so as to determine thelocation of the heat sources, and, in particular, any dominant thermalsource within the module during use. Such thermal source information maybe added to a thermal model of the module so as to more preciselypredict the heat transfer through the device during use. In one usagescenario, a controlled heating of one or more components may be used aspart of a calibration procedure.

In some usage scenarios, the insulation of the clothing, blanket, etc.on the subject may influence the heat transfer from the subject to theenvironment. Thus the heat flux through the module may change along withthis level of insulation. In one non-limiting example, when the heatflux through the module approaches zero, the skin temperature mayapproach that of the core temperature of the subject.

In one non-limiting usage scenario, the module and/or patch may includeone or more electromyographic sensors so as to determine local muscleactivity during use. Optionally, the module and/or patch may alsoinclude one or more stretch sensors and/or one or more inertial sensorsso as to determine movement of one or more nearby muscle groups duringuse. During a period of physical activity, the extent and type of muscleactivity may be determined by the EMG sensor, the activity sensor,and/or the stretch sensor. Simultaneously, one or more of thetemperature sensors may be monitored before, during, and/or after thephysical activity to determine the local temperature increase and/orheat transfer from the muscle during use. Collectively, such informationmay be combined so as to determine the energy expenditure of the musclegroup as well as the efficiency of the muscle group to the physicalactivity under test. Such information may be used to guide training,demonstrate changes in the capability and/or efficiency of a musclegroup over time, to determine the extent of muscle strengthimprovements, etc. during use. Such information may be advantageous fordetermining/guiding progress of a subject during physiotherapy, duringtraining, for evaluating the athletic capability of a subject, etc.

In one non-limiting usage scenario, in particular directed towards careof an infant or a premature infant in a Kangaroo care setting, apatch-module pair may be placed onto the torso of the infant. Inaspects, the device may include a plurality of temperature sensors, oneor more inertial sensors, one or more orientation sensors, one or morepulse oximetry sensors, one or more electrocardiographic sensors, one ormore respiratory sensors, one or more humidity sensors, or the like.

The plurality of temperature sensors may be used to determine the stateof contact between the infant and the mother. In particular, when theinfant is optimally oriented against the body of the mother, the thermalgradient measured by the plurality of the temperature sensors mayapproach zero, the temperature measurements obtained from the sensorsmay approach the body temperature collectively of the mother and theinfant, the orientation sensors may indicate that the head of the infantis correctly oriented with respect to gravity (e.g., the head of theinfant is oriented up with respect to gravity), the heart rate of theinfant is in a normal range, the humidity of the environment around theinfant is high, the SpO2 reading of the infant is within a normal range(e.g., greater than 96%). When the orientation and/or positioning of theinfant with respect to the parent is sub-optimal, one or more of thesubsystems may provide corresponding information, and an alert may bemade, a feedback signal to the parent figure to assist with correctingthe positioning of the infant, or the like may be made. Such a systemmay be advantageous to assist a parent figure with performing ofKangaroo care in a general usage environment.

In one non-limiting embodiment, a patch used in a Kangaroo care scenariomay be configured with a plurality of electrophysiologic sensors (e.g.,electrodes). The plurality of electrodes may include two or more downfacing electrodes positioned so as to contact the skin of the infantduring use, and two or more up facing electrodes positioned so as tocontact the skin of the parental figure during proper implementation ofKangaroo care. In one usage scenario, when the infant is properlypositioned against the skin of the parental figure, the up facingelectrodes may contact the skin of the parental figure. The up facingelectrodes may be coupled to one or more circuits used to determine theskin impedance of the parental figure, one or more electrophysiologicsignals from the parental figure, and/or one or more electrodermalsignals from the parental figure. In aspects, the down facing electrodesmay be used to determine one or more similar signals from the infant.During proper implementation of the Kangaroo care procedure, theelectrophysiologic information from both parent and child may bedetermined. In aspects, the characteristics of the electrocardiographicsignal obtained from the up facing electrodes may be used to determinethe position of the infant against the torso (e.g., with respect toorientation of the heart) of the parent figure during use. Suchinformation may be combined with the orientation information obtainedfrom the orientation sensors to determine the orientation state of theinfant with respect to gravity as well as with respect to the torso ofthe parental figure during use.

In one non-limiting application, an embodiment in accordance with thepresent disclosure may be used to monitor a subject for heat exhaustion,dehydration, fatigue, or the like. In such usage scenarios, theembodiment may include a plurality of sensor types including one or moretemperature sensors, one or more electrophysiologic sensors, one or moreactivity sensors, one or more orientation sensors, or the like. Duringuse, a data set may be generated from data collected with each sensorsystem, the data set collectively containing data related to thephysiologic state of the subject, the orientation of the subject, andthe state of the environment in the vicinity of the subject. Somenon-limiting examples of collected data may include ECG, heart-rate,heart-rate-variability, Q-T period, ST segment amplitude, QRS amplitude,respiration rate, respiration depth, respiration character, skintemperature, core temperature, local heat flux, local orientation, localinertial information, local humidity, low air temperature, local airflowrate, and the like. The changes of the physiologic data (e.g., ECG,heart rate, respiration, etc.) in combination with movement, andenvironmental information, may be correlated to assess the fatiguestate, hydration state, and/or heat exhaustive state of the subject.

In one non-limiting example, the correlation may be determined bycomparing the heart rate recovery (HRR) and/or temperature recovery ofthe subject after a period of physical activity. As the subject becomesexhausted, the HRR changes, temperature recovery changes, and HRVchanges with respect to the relationships observed during a normal stateof the subject. Thus it may be advantageous to monitor the interactionof the ECG, respiration, and thermal changes in a subject measured inreal-time during activity to determine the fatigue state, and/orhydration state of the subject.

FIG. 21 shows an example of such a patch 2100 attached to a subject2101. The patch 2100 includes an adhesive layer or substrate 2110,having regions 2115 a and 2115 b as shown. The regions 2115 a and 2115 bmay be insulating and thermally conducting regions, respectively. Thepatch 2100 includes sensors 2120 a, 2120 b, 2120 c. Sensor 2120 a isconfigured to interface with the skin 2102 of the subject 2101 in theinsulating region 2115 a, while sensor 2120 b is configured to interfacewith the skin 2102 of the subject 2101 in the thermally conductingregion 2115 b. Sensor 2120 c is placed opposite the skin-interfacingside of the patch 2100 and is configured to measure ambient orenvironmental properties. While FIG. 21 shows an example wherein thepatch 2100 includes a single insulating region 2115 a and a singlethermally conducting region 2115 b, embodiments are not limited to thisarrangement. A patch or other sensing device may more generally includemultiple insulating and/or thermally conducting regions. In addition,while patch 2100 shows the insulating region 2115 a and thermallyconducting region 2115 b on left and right sides of the patch 2100, thisis not a requirement. In some cases, an insulating region may surround athermally conducting region, or vice versa.

A number of use cases for measuring body temperature, physiologiceffects of dehydration, and fatigue with a modular physiologicmonitoring system including a patch or sensor as described above arepresented below. It is to be appreciated, however, that theseillustrative use cases are provided by way of example only and thatembodiments are not limited solely to these specific use cases.

The patch may be placed on the subject while the subject is exercisingin an outdoor environment. Although the environmental conditions and theexertion of the subject may change dramatically during the workout, thesystem as configured is capable of making core temperature measurementsand heat loss measurements with improved precision relative to basicskin temperature measurements.

The patch may be placed on the subject while the subject goes to sleepunder covers of a bed. Under the covers, the humidity may increasedramatically during the night, and the thermal gradient may be markedlyreduced. A modular physiologic monitoring system including the patch orsensor is capable of tracking the core temperature of the subject withimproved precision over basic skin temperature measurements.

The patch may be placed on the subject while the subject goes to thebeach on a hot, sunny day. In addition to temperature, thermal gradientand local environmental conditions, the sensors in the patch can measurelight-based information, such as exposure to ultraviolet (UV) orinfrared (IR). The system can thus track core temperature of the subjectand heat loss, as well as light exposure during the trip.

In some embodiments, measurements or data received from sensors in thepatch may be used to measure temperature, sweat flux, respiration rate,ECG, respiration depth, acceleration or activity sensing, pulmonarycompliance as per congestive heart failure (CHF) protocols, sweat rate,etc.

Temperature may be measured with temperature sensors, and may beassociated with one or more of skin under thermal vasodilation, skinambient temperature, environmental ambient temperature, sweattemperature, etc.

Sweat flux may be a volumetric measure, such as milliliters per minute(mL/min). The patch may be configured with features to facilitatepolymer wicking and/or cooling. The volumetric rate of sweat may becorrelated with temperature, activity, ambient temperature, etc.

Respiration rate of the subject may be correlated with activity sensors,recorded after activity, etc.

ECG may be measured with one or more hubs/electrodes connected to thepatch or patches. ECG may be used to identify HR recovery and activity(HR acceleration) relationships. Rate and variability may also bemeasured with ECG. The ST segment of the ECG may be correlated withstrain.

Respiration depth may be measured via diaphragmatic extension and/orcontraction using localized EMG and spatial tracking.

Acceleration and activity sensing may be measured with sensors placed onthe body to identify movement of or change in center of mass, appendages(e.g., legs, arms, hands, etc.).

Pulmonary compliance, per CHF protocols, may be used for flow estimationby pressure and gradient. External and handheld sensors, such ascalibrated tubes, may be used to measure pressure gradients. Intraoralor intranasal sensors include mouthpiece barometers, tooth or intranasalstent barometers, etc. Measurements from intraoral and/or intranasalsensors may be referenced to ambient pressure on a hub or patchconnected elsewhere on the body of the subject. Barometry may be used tomeasure pressure gradients, such as intranasal versus ambient pressure.Barometry may also or alternatively be used to sense inhalation and/orexhalation force, to make approximate conversions to flow, etc.Inhalation and/or exhalation force may be increased with low pulmonarycompliance. Time averages of barometer readings and other sensorreadings may be utilized.

Measuring or predicting the sweat rate of a subject may includemeasuring or estimating core temperature of the subject, skintemperature, breathing (e.g., depth, rate, duty cycle, etc.), subjectactivity, ECG information, or other physiologic parameters describedabove. One or more aspects of the environment around the subject mayalso be measured in conjunction with the physiologic parameters of thesubject. Ambient or environmental parameters which may be measuredinclude but are not limited to local temperature, humidity, sunintensity, altitude including changes in altitude (e.g., such as changesoccurring during stair or hill climbing, etc.), heat transfercoefficients between the subject and the surroundings of the subject,etc. Heat transfer coefficients may be a key parameter that can take theplace of or be representative of various ambient or environmentalparameters.

The weight of the subject may be precisely measured at intervals,including but not limited to before and after a workout, before andafter defecation, before and after sleep, before and after resting in acontrolled climate (e.g., a sauna, a bathtub, etc.), or the like. Theweight of the subject may be utilized to estimate or predict sweat rateof the subject.

Relationships between temperature measurements, ambient or environmentalmeasurements, weight measurements, etc. may be correlated with exertionlevels and environmental effects. From the determined relationships,which may be collected over one or multiple sessions, types of workouts,climate types, etc., the sweat rate prediction algorithm is generated.The sweat rate prediction algorithm looks to and compares physiologicstate, activity state and environmental state with a database to predicta sweating rate of the subject. The sweat rate may be used to predicthydration needs of the subject during current activities to maintainoptimal hydration.

A modular physiologic monitoring system for monitoring and management ofbody temperature and systemic fatigue may include a heating element, amoisture collection element, etc. whereby the sweating response of thesubject in the region of the body to which the patch is attached may bedetermined as it correlated to skin temperature, and to skin temperatureversus central mediating aspects such as core temperature, blood saltconcentration, etc.

Modular physiologic monitoring systems for monitoring and management ofbody temperature and systemic fatigue may further include variousstimulating devices, which may be used to apply stimulus includingmulti-modal stimulus to the subject in response to measurements from thesensing device or patch attached to the subject. Such stimulus may be inthe form of heating or cooling the subject, triggering alarms or alerts(e.g., visual or audible) upon detecting events such as thresholds forcore temperature, sweating rate, etc. where the alarms or alerts areprovided directly to the subject, to a caregiver or other individualassociated with the subject such as a coach or medical staff, etc.

FIG. 22 shows a patch 2200 with reusable component 2225 for monitoringinterfacial pressure along a region of a subject. The patch 2200includes a plurality of microcells 2210 arranged in a thin, flexiblelaminate 2205. The patch 2200 may include an adhesive for attachment tothe body of a subject. The patch 2200 is attachable to the reusablecomponent 2225 via a connector 2230. The patch 2200 may include aplurality of electrical traces arranged so as to connect the microcells2210 to the connector 2230. The connector 2230 includes a manifold 2240to direct a fluid to one or more of the microcells 2210 as well as oneor more pressure sensors 2235 to measure local pressure in one or moreof the microcells 2210. The reusable component 2225 includes a micropump2245 for directing fluid flow to/from the microcells 2210 and a powersource 2240 such as battery. The reusable component 2225 may alsoinclude a vent 2255 to adjust the internal pressure of the reusablecomponent 2225 with the surroundings. The connector 2230 may interfacewith a locking mechanism 2220 so as to secure the reusable component2225 to the patch 2200. The reusable component 2225 may include awireless communication 2250 subsystem, the subsystem configured so as toconvey an interfacial pressure reading as monitored by one or more ofthe microcells 2210 to a host, stimulating device, or the like. Such asystem may be advantageous for monitoring a local interfacial pressurein real-time, determining the duration of pressure application to alocal region of a subject, determining when pressure application to aregion of a subject exceeds a predetermined level or duration, etc.

FIG. 23 shows a plot of output measured by the reusable component 2225to interfacial pressure application to a microcell 2210 in the patch2200. The pressure level in the microcell 2210 is substantially linearand with minimal hysteresis so as to precisely determine the pressureapplied to the microcell 2210 on the subject. The patch 2200 is providedas a thin, soft laminate with stable microchannels coupling themicrocells 2210 to the connector 2230. The patch 2200 may be provided asa substantially thin and stretchable laminate film, the patch 2200 mayhave a total thickness of less than 100 μm, less than 50 μm, less than25 μm, or the like.

FIGS. 24a-24c shows a modular physiologic monitoring system 2400. Themodular physiologic monitoring system 2400 includes a sensing device2410 and a stimulating device 2420 attached to a subject 2401 that arein wireless communication 2425 with a host device 2430. The host device2430 includes a process, a memory and a network interface.

The processor may comprise a microprocessor, a microcontroller, anapplication-specific integrated circuit (ASIC), a field-programmablegate array (FPGA) or other type of processing circuitry, as well asportions or combinations of such circuitry elements.

The memory may comprise random access memory (RAM), read-only memory(ROM) or other types of memory, in any combination. The memory and othermemories disclosed herein may be viewed as examples of what are moregenerally referred to as “processor-readable storage media”storingexecutable computer program code or other types of software programs.Articles of manufacture comprising such processor-readable storage mediaare considered embodiments of the invention. A given such article ofmanufacture may comprise, for example, a storage device such as astorage disk, a storage array or an integrated circuit containingmemory. The processor may load the computer program code from the memoryand execute the code to provide the functionalities of the host device2430.

The network interface provides circuitry enabling wireless communicationbetween the host device 2430, the sensing device 2410 and thestimulating device 2420.

FIG. 24a illustrates a modular physiologic monitoring system 2400 thatincludes only a single instance of the sensing device 2410 and thestimulating device 2420 for clarity. It is to be appreciated, however,that modular physiologic monitoring system 2400 may include multiplesensing devices and/or multiple stimulating devices. In addition,although FIG. 24a illustrates a modular physiologic monitoring system2400 in which the sensing device 2410 and the stimulating device 2420are attached to the subject 2401, embodiments are not limited to sucharrangements. As described above, one or more sensing and/or stimulatingdevices may be part of contacting surfaces or non-contacting devices. Inaddition, the placement of sensing device 2410 and stimulating device2420 on the subject 2401 may vary as described above. Also, the hostdevice 2430 may be worn by the subject 2401, such as being incorporatedinto a smartwatch or other wearable computing device. The functionalityprovided by host device 2430 may also be provided, in some embodiments,by one or more of the sensing device 2410 and the stimulating device2420.

FIG. 24b shows a schematic of aspects of the sensing device 2410 inmodular physiologic monitoring system 2400. The sensing device 2410includes one or more of a processor, a memory device, a controller, apower supply, a power management and/or energy harvesting circuit, oneor more peripherals, a clock, an antenna, a radio, a signal conditioningcircuit, optical source(s), optical detector(s), a sensor communicationcircuit, vital sign sensor(s), and secondary sensor(s). The sensingdevice 2410 is configured for wireless communication 2425 with thestimulating device 2420 and host device 2430.

FIG. 24c shows a schematic of aspects of the stimulating device 2420 inmodular physiologic monitoring system 2400. The stimulating device 2420includes one or more of a processor, a memory device, a controller, apower supply, a power management and/or energy harvesting circuit, oneor more peripherals, a clock, an antenna, a radio, a signal conditioningcircuit, a driver, a stimulator, vital sign sensor(s), and secondarysensor(s). The stimulating device 2420 is configured for wirelesscommunication 2425 with the sensing device 2410 and host device 2430.

FIG. 25 illustrates a state diagram for monitoring the interfacialpressure of a region of a subject during use. The state diagramillustrates a non-limiting methodology for abstracting the movementstate of the subject and the corresponding state of the region ofinterest. The methodology may be used to translate a touch and/or painsensation from the region of interest of the subject to another regionof the subject (e.g., a region of the subject with functioning neuralreceptors). In one non-limiting example, such a system may be used totransfer touch and pain related information from a region of a subjectsuffering from peripheral neuropathy to a region of a subject that isunaffected by the condition. In such a scenario, the informationgathered may be used to make the user aware of unexpected impacts to theaffected region, touch sensation on the region, prolonged pressureapplication to the region (e.g., making that region vulnerable topressure ulcer formation), to assist with gait, to assist withcorrecting and/or relearning gait in a physiotherapy setting, etc.

The system starts in a watchful mode after transitioning 2501 from astart-up mode after power up. The system transitions to one or morestates depending on the inputs monitored by the system. The system maytransition 2502, 2506, 2514, 2525 to an abstracted state relating to thestate of the subject, such as: a startled response mode (e.g., whereinan impact is registered on a region of interest) via transition 2502; agait sense sync mode wherein gait sensing is detected (e.g., walkingrelated movement) via transition 2506; a prolonged sensation mode (e.g.,wherein substantially steady pressure is applied to the region ofinterest) via transition 2514; and a resting mode (e.g., wherein thesubject or the region of interest thereof is not moving or has movementbelow a specified threshold) via transition 2525.

In the startled response mode, the system may transition 2504 to a painand alarm mode on determining that applied pressure exceeds a threshold.The system transitions 2505 back to the startled response mode and thentransitions 2503 back to the watchful mode on determining that theapplied pressure reaches a normal level, after a specified timefollowing impact to the region of interest, etc.

In the gait sense sync mode, the movement of the subject and periodicpressure application to the monitored region are collectively used totime a stimulus response to the subject via a corresponding stimulatingdevice. During movement associated with the gait, the system may monitorfor pressure levels on the monitored region that may exceed painthresholds, whereby if such an occurrence happens, the system maytransition 2508 into a gait pain sync mode, whereby the stimulusamplitude, duration, or type of nerves elicited (e.g., altering thestimulus protocol so as to activate pain fibers at the stimulatingdevice site), is altered to signify a pain response to the subject. Inthe case that an impact or exceedingly high pressure is applied to themonitored region, the system may transition 2512 into a sync alarm modeto provide an aggressive stimulus to the subject to prompt immediateresponse to an excessive pressure application or impact to the monitoredregion. From the gait pain sync mode and the sync alarm mode, the systemmay transition 2509, 2513 to a reduce watch mode after remediation. Fromthe reduce watch mode, the system may transition 2510 back to the gaitpain sync mode if the pressure levels on the monitored region againexceed pain thresholds, or transition 2511 back to the gait sense syncmode and from the gait sense sync mode transition 2507 back to thewatchful mode after a specified time, after determining that the subjectis no longer in a walking mode or other gait sensing activity, etc.

In the prolonged sensation mode, the system may transition 2515 to aprolonged pain mode if an applied pressure to the region of interestexceeds a threshold, indicating that the applied pressure should beeliciting a pain response from the monitored region (e.g., if the neuralfunctionality in the affected region was normal, the subject would haveregistered pain in the monitored region). The system may transition to aprolonged watch recover mode (e.g., via a direct transition 2518 fromthe prolonged sensation mode or via a transition 2520 from the prolongedpain mode) when pressure application is sufficiently low. The system maytransition 2516 to a prolonged startle mode, wherein a correspondingstimulating device may begin stimulating the subject so as to prompt thesubject to move or otherwise to adjust pressure on the monitored region.If the subject does not respond, the system may transition 2517 to analarm state, activating one or more alerts to more aggressively promptthe user to alleviate pressure from the monitored region. In a hospitalor other managed care setting, alerts may be provided to a caregiver soas to prompt the caregiver to take action if the pressure application tothe affected area has exceeded a safe threshold for a prolonged periodof time. The system may transition 2522 or 2523 from the prolongedstartle mode or alter mode, respectively, following remediation (e.g.,adjusting the pressure on the monitored region). The system maytransition 2521 from the prolonged watch recover mode to the prolongedpain mode following determination that the applied pressure has exceededthe threshold. The system may transition 2519 back to the prolongedsensation mode or transition 2524 back to the watchful mode from theprolonged watch recover mode after a specified time, after determiningthat the applied pressure reaches a normal state, etc.

In the resting mode, the system may transition 2526 to a sensationdetection mode if pressure application is detected on the region ofinterest or transition 2528 to an indirect watch mode if movement hasstopped for a prolonged period of time. In either case, the system maytransition to an alert mode if a time/pressure metric has been exceeded(e.g., a direct transition 2527 from the sensation mode or a transition2531 to the sensation mode from the indirect watch recover mode followedby the transition 2527 from the sensation mode to the alert mode).Transitions 2532, 2530, 2529 and 2533 may be used to return to theindirect watch recover mode, resting mode and/or watchful mode ifpressure is removed or movement is restored within an allottedtimeframe.

FIG. 26 illustrates a state diagram for monitoring the posture andvitals of a subject during a usage procedure. On power up, the systementers a start-up mode and then transitions 2601 to a wait mode, wherethe system generally waits for the user to enter a state such as amovement state, a change in posture, a cyclic movement state, etc.

In response to detecting defined types of movement of the subject or aregion of interest thereof, the system transitions 2602 to an assessmovement mode. In the movement assessment mode, the system monitors themovement of the subject to look for certain types of movement events,such as unusually wandering, periodic movements, a fall, etc. If adangerous movement is detected, the system may enter the requestfeedback mode (e.g., via transitions 2604/2606/2608/2610 or viatransitions 2604/2607/2610) and/or the assess vitals mode (e.g., viatransitions 2604/2607 or 2604/2606/2608). Although not explicitly shownin FIG. 26, there may also be direct transitions from the assessmovement mode to the request feedback mode and the assess vitals mode,which do not pass through the alert, emergency help and/or assess vitalsmodes. In the feedback mode, the system may prompt the subject or acaregiver for feedback, such as via a microphone embedded in one or moresensing devices. In the assess user vitals mode, the system may utilizeone or more of the sensing devices to assess one or more physiologicparameters of the subject. If the subject is in a fallen state or otherundesired state but the vital signs are substantially normal, the systemmay transition to alert mode wherein one or more stimulating devicesprovide stimulus alerting the subject to correct the undesired state. Ifthe subject is in the undesired state and the vital signs are dangerousor otherwise not normal, the system may transition to the emergency helpstate whereby outside help is contacted. In the emergency help state,the system may communicate the location of the subject (e.g., vialocation information provided by a location service or via locationinformation obtained from one or more of the sensing devices), theposture of the subject, vital sign information, etc. so as to assist acaregiver or emergency personnel. Various transitions 2604 through 2611may be used to move between the assess movement mode, alert mode,emergency help mode, assess vitals mode and request feedback mode asillustrated in FIG. 26. As indicated above, however, the system may alsoinclude direct transitions between certain modes, such as a directtransition from the assess movement mode to the request feedback mode orfrom the assess movement mode directly to the assess vitals mode, etc.which are not shown for clarity of illustration.

In response to detecting a change in posture, the system transitions2613 to the assess posture state. The state of the posture of thesubject is then monitored and, if the subject's posture is outsidepredetermined bounds, the system may transition 2615/2616 to/from asense and correct mode where one or more stimulating devices areactivated to send a stimulus to the subject so as to correct the postureof the subject. The system may alternatively transition 2617/2618to/from a reset mode, wherein one or more stimulating devices providestimulus to cause the subject to reset his or her posture, or whereinone or more sensing devices are configured to re-determine a posture ofthe subject. On remediating postural issues, the system may transition2614 back to the wait mode.

In response to detecting cyclic movement seen on a subject, the systemtransitions 2619 to an assess cyclic movement mode. Based on assessmentof the cyclic movement, the system may: transition 2621/2622 to/from ahip or knee adjust mode; transition 2623/2624 to/from a phase shift andsync mode; transition 2625/2626 to/from an adjust amplitude mode; ortransition 2627/2628 to/from an adjust in-foot mode. In the hip or kneeadjust mode, phase shift and sync mode, adjust amplitude mode and adjustin-foot mode one or more corresponding stimulating devices applystimulus to the subject, such as stimulus to direct the subject to makechanges to their gait or other cyclic movement. If cyclic movement is nolonger detected, the system may transition 2620 back to the wait mode.

FIG. 27 illustrates a method which may be performed utilizing a modularphysiologic monitoring system as described herein. The methodillustrated in FIG. 27 may be considered a method from the perspectiveof a host device in a modular physiologic monitoring system. It is to beappreciated, however, that the host device may be implemented at leastin part utilizing one or more sensing and/or stimulating devices of amodular physiologic monitoring system as described elsewhere herein.

The method begins with step 2702, receiving monitoring data from atleast one sensing device coupled to a subject. In step 2704, themonitoring data is analyzed to identify one or more physiologicparameters of the subject. Signaling is provided to at least onestimulating device in response to the identified physiologic parametersin step 2706. The signaling comprises instructions to apply a stimulusto the subject.

The method continues with step 2708, receiving additional monitoringdata form the at least one sensing device, such as additional monitoringdata after application of the stimulus to the subject. The additionalmonitoring data is analyzed in step 2710 to identify one or more changesin the one or more physiologic parameters of the subject afterapplication of the stimulus to the subject. In step 2712, additionalsignaling is provided to the at least one stimulating device. Theadditional signaling comprises instructions to modify the stimulusapplied to the subject based on the identified changes in the one ormore physiologic parameters. Modifying the stimulus may include endingapplication of the stimulus, adjusting a frequency, amplitude orstrength of the stimulus, changing the type of stimulus applied to thesubject, etc.

Modular physiologic monitoring systems described herein can monitor andsave or store various types of data, including data relating to a widevariety of physiological parameters of a subject. The particularparameters which are measured may vary depending on the configurationand/or placement of the one or more sensing devices. The one or moresensing devices may include various types of sensors, including but notlimited to sensors for measuring EEG, EOG, EMG of various muscle groups,audible inputs (e.g., internal body sounds from down facing microphones,external audible sounds from outfacing microphones), kinematicsincluding orientations, movements, movements associated withrespiration, respiration efforts, etc. In addition, one or more sensingdevices may be configured to monitor local tissue stretch, which can beused as an independent respiratory monitor, respiratory depth monitor,etc. Based on placement of the one or more sensing devices,electrophysiological signals may be monitored at any desired location.Such electrophysiological signals include but are not limited to basicmyography (e.g., ECG, EMG, neuro, etc.) along with the sudomotor, neuralreceptor field, and vasomotor additions. Described below are variousexamples of data which may be obtained using one or more sensing devicesduring a monitoring session. Unless otherwise noted, the data describedbelow and shown in the accompanying figures represents raw data. Asdescribed elsewhere herein, the sensing devices and/or the host devicemay be configured to format or combine multiple types of raw data toestablish relevant information associated with a particular event, suchas an apneic event.

During testing, sensing devices may monitor one or more of the followingoutputs: ECG (with any desired lead configuration); EMG (with anydesired lead configuration); sudomotor function (anywhere, includingglabrous or non-glabrous tissues); vasomotor function (anywhere,including glabrous or non-glabrous tissues); receptor field measurements(such as using multi-electrode patches and chips); optical measurements;blood pressure trends; cardiac index; cardiac output; oxygen delivery;indexed oxygen delivery; maximum pressure slope during systole; fingerarterial blood pressure waveform; hydrostatic compensation referencesystem (good for tilt testing, posture changes, etc.); inter beatinterval; stroke volume; stroke volume index; systemic vascularresistance; systemic vascular resistance index; stroke volume variation;plethysmogram; non-invasive arterial oxygen saturation; perfusion index;pulse pressure variation; total hemoglobin; etc.

Captured physiologic data, including data relating to BP and ECG may befurther analyzed to capture various parameters. For BP analysis,parameters such as systolic pressure, diastolic pressure, dicrotic notchtiming and pressure, mean pressure, pulse pressure, ejection duration,non-ejection duration, cycle duration or HR from BP, time to peak, meandiastolic pressure, etc. may be assessed. Cycle-to-cycle waveforms mayalso be analyzed, such as comparing waveforms at different times in atest, etc. Dynamic metrics may also be generated from temporal curves.For ECG analysis, parameters such as R-R interval(s), heart rate (BPM),PR interval(s), P duration(s), QRS interval(s), QT interval(s), QTc(s),JT interval(s), Tpeak Tend interval(s), P amplitude (in millivolts(mV)), Q amplitude (in mV), R amplitude (in mV), S amplitude (in mV), STheight (in mV), T amplitude (in mV), etc. Higher frequency analysis mayalso be performed, such as extracting EMG baselines, which may be usefulas certain electrodes that are not close to contracted muscles may showa significant change in higher frequency content which may be related tosympathetic nerve activity (SNA).

Various sensing devices of a modular physiologic monitoring system maymeasure various parameters of a subject to monitor for variousconditions, such as sleep apneic events as described herein. Theparticular physiologic parameters or other metrics that are measuredusing the sensing devices may be selected based on the number and/ortype of sensing devices available, for comfort of the subject, based onwhich autonomic changes are most relevant for detecting a particularevent, etc.

In some embodiments, sensing devices in a modular physiologic monitoringsystem may provide raw data, or data which includes only basicfiltering, to a host device. Further filtering may be performed, withfeature extraction algorithms to pull out information from the raw dataassociated with the state and actions of the subject. The filtering maybe performed by the sensing devices in a modular physiologic monitoringsystem, or by a host device or one or more stimulating devices in themodular physiologic monitoring system configured for communication withthe sensing devices. In some embodiments, it is desired to offloadfiltering, feature extraction and other processing to the host device soas to reduce a processing burden on the sensing devices, which mayincrease the battery life of the sensing and/or stimulating devices,decrease the cost associated with the sensing and/or stimulating devicesby not requiring powerful or sophisticated processing and/or memorycomponents, etc.

Signals associated with physiologic parameters of a subject may becollected in real time, combined and analyzed as part of a multipleinput multiple output (MIMO) modular physiologic monitoring system todetermine the state of the subject (e.g., utilizing one or more sensingdevices), identify if an event is happening and the event type (e.g.,utilizing a host device, the one or more sensing devices and/or one ormore stimulating devices) and then provide a stimulus to the subject(e.g., utilizing one or more stimulating devices).

In some embodiments, a modular physiologic monitoring system may beconfigured to remotely communicate the health status of a subject. Thesystem can provide multimodal measurement of physiologic parameters suchas HR, skin temperature, respiration, clinical ECG, thermal gradientsfor core temperature predictions, movement, posture, etc. The system mayutilize one or more patches and/or patch-module pairs. The patches areultra-wearable, including hypoallergenic and stretchable microelectroniccomponents and bioadhesives. Such patches and/or patch-module pairs areconfigured to remotely monitor and transmit health data from a subjectto a command post, such as a host device, over the duration of a missionor wear period.

A modular physiologic monitoring system may be designed for use in highstress applications, and is configured to continue operation undervarious conditions including high sweat, dynamic movement, duringshowering, and the like. The modular physiologic monitoring system canalso be built to be skin safe, breathable and incredibly comfortable forthe subject. Such comfort is provided, in some embodiments, through theuse of thin and stretchable patches that act as an extension of theskin, and as such a subject does not substantially feel that the patchor patch-module pair is being worn. The patch or patch-module pair islightweight and does not cause skin irritation. Skin safety is provided,in some embodiments, by the design of the patches and/or patch-modulepairs for chronic wear with all adhesive components beinghypoallergenic, breathable (e.g., with minimal maceration risks) andstretchable, so as to limit pull on attached tissues during dynamicusage scenarios. Sensors included in the patches and/or patch-modulepairs are design such that they can be placed on the subject withoutrequiring the subject to remove clothing.

Communication of data from the patches and/or patch-module pairs may beperformed via a local personal communication device (PCD). Suchcommunication in some embodiments takes place in two parts: (1) localcommunication between a patch and/or patch-module pair (e.g., via a hubor module of a patch-module pair) and the PCD; and (2) remotecommunication from the PCD to a back-end server. The PCD and back-endserver may collectively provide functionality of the host device asdescribed elsewhere herein.

In some embodiments, the modular physiologic monitoring system utilizesone or more patch-module pairs. The patch, as described elsewhereherein, may provide a disposable subject interface. The module or hub,as described elsewhere herein, may provide a reusable hardwarecomponent. The hub may have a diameter of approximately 20 mm at itslongest width, with a thickness of approximately 5.5 mm at its thickestpoint. The hub may weigh approximately 2.1 grams. The hub ishermetically sealed, rechargeable, and has a life expectancy in serviceof at least one year. The patch is disposable, breathable and tailoredto wear times ranging from 1 day to 1 week. The wear times may be basedon usage scenarios, climate, etc. The system may be built to accommodatea range of usage cases, including showering, hot environments, extremesweating, etc.

To apply a patch-module pair, the subject can peel a liner off of anadhesive portion of the patch, and adhere the patch firmly to the skinat a desired measurement site (e.g., a sternum for ECG). The attachmentprocess is analogous to that of attaching a small bandage. The subjectthen attaches the hub/module to the patch to start recording andwireless data transfer. Necessary or desired metrics representing thehealth of the subject are generated locally. System accuracy may varybased on the usage case and attachment location.

The patch in some embodiments is designed to be soft and stretchable,such that the subject generally does not feel that the patch is beingworn. The patch moves intimately with the skin of the subject withoutappreciably pulling on the skin during use. In some embodiments,electrodes on the patch are configured to locally hydrate the adjacenttissues to quickly lower epidermal impedance. Fluid balance at theelectrodes may be maintained through vapor transfer through theelectrode films.

Skin-electrode interfaces and interconnects are isolated fromsurroundings via hydrophobic bioadhesives and hydrophobic films in thepatches. Thus, the patches will not succumb to water breach in usagescenarios such as showering, extreme humidity, rain, water soakedclothing, etc.

Movement artifacts are dramatically reduced by the soft mechanicalnature of the stretchable interconnects and the minimal relativemovement between the hub/module hardware and the adjacent tissues.Furthermore, strategic placement of the patch-module pairs away fromlarge muscles helps to passively reduce EMG artifacts. In one usagescenario, patch-module pairs may be placed on the upper torso near thesternum to help reduce EMG related artifacts.

Preamplifiers are located immediately at measurement sites, and withminimal relative movement therebetween. Current pathways are alsolocally balanced. There is no or very limited movement between thepatch-module pair and the skin of the subject, thus eliminating orreducing lead movement artifacts.

Hubs/modules are tough, hermetically sealed and attached to anaccompanying patch via a combination of magnetic interconnects and anadhesive gasket. The gasket provides a hermetic seal around theinterconnects and has a high peel strength, while the magneticinterconnects maintain secure electrical contact between the hub/moduleand patch during use. The attachment between the patch and thehub/module can be tailored to balance removal of the hub/module forhot-swapping and reuse and secure holding during dynamic movement of thesubject. In some embodiments, the hub/module attaches securely to thepatch with a holding force of greater than 0.5 kilogram-force (kgf),greater than 1 kgf, greater than 2 kgf, greater than 3 kgf, or the like.

FIG. 28 illustrates a patch-module pair attached to the skin of asubject, including a hub/module 2802 and a patch 2804. The hub/module2802 provides a wearable unit, and the patch 2804 provides anultra-breathable and wearable skin interface. FIG. 28 illustrates thepatch-module pair attached to a torso of a subject. Demonstration of theholding force is illustrated via a patch-module pair including hub 2902and patch 2904 attached to the forearm of a subject in FIGS. 29a and 29b.

When placed on the torso, patch-module pairs may collect a diagnosticgrade ECG of the subject during use. By collecting the full ECG, asignal quality metric may be created along with a confidence intervalrelating to the quality of the captured signal. In addition to the ECG,further physiologic information associated with the subject's healthstate may be collected by the hub/module in the form of secondary sensorreadings. This provides significant advantages to conventionaltechniques, which may only record an average R-R interval as an estimateof heart rate (e.g., conventional arrangements may only generallyestimate the R-R interval via a hardware comparator or via peak analysison an SpO2 reading, and thus the entire ECG is not available for furtheranalysis). Such an approach may be advantageous to provide a confidenceinterval around an ECG generated metric, such as heart-rate. Such aconfidence interval may be used to determine if the data collected is ofsuitable quality so as to trust it (e.g., so as to confirm it isactually related to the R-R interval of the ECG of the subject, and notdue to a movement artifact, respiration, EMI, etc.).

FIGS. 30 and 31 show examples of raw data associated with collectedphysiologic signals using a patch-module pair. The raw data was takenfrom a stationary subject, and show initial tracings. FIG. 30 shows arecorded ECG, and FIG. 31 shows a PPG tracing. The PPG in this exampleis used as a secondary sensing modality. In the context of PPG, thepatch-module pairs allow for controlled force application to adjacenttissues and minimization or relative movement, which often plagues PPGreadings using conventional techniques. Thus, illustrative embodimentsprovide for more consistent PPG recordings relative to conventionalarrangements.

In addition to measuring electrophysiologic signals, a patch-module pairmay be configured to obtain various temperature-related measurements.The hub/module, for example, may include several temperature sensors.One sensor, which may be locally insulated from the environment by thehub/module, may be positioned to monitor temperature directly at theskin of the subject. Another sensor, locally insulated from the skin bythe hub/module, may be positioned to monitor temperature at the top ofthe hub/module. Additional sensors may be placed throughout thehub/module to assist with calibration, heat flux calculations and thelike. By measuring temperature at multiple strategic sites, a betterestimate of core temperature of the subject may be generated, along withthermal gradients, ambient temperature and humidity changes, etc. Amodular physiologic monitoring system may thus be configured to generateimproved predictions of core temperature, and provide a confidencemetric on core temperature readings during normal usage scenarios.Additional details regarding patches, hubs/modules and patch-modulepairs configured for such measurements of core temperature are discussedabove.

In some embodiments, a wide variety of types of secondary sensors may beused in a hub/module, including but not limited to temperature sensorsfor measuring body temperature, ambient temperature, thermal gradients,local humidity, etc., top and/or down facing microphones, dead reckoningkinematic sensing to back up physiologic measurements and improverobustness (e.g., allowing for postural assessment, movement assessment,secondary breathing assessment, etc.). Further positional data andnear-field locational data may be obtained from the patch in apatch-module pair.

A communication profile which may be used in a modular physiologicmonitoring system will now be described, wherein a PCD performs hostfunctions a hub/module acts as a peripheral. A wireless communicationlink between the hub/module and the PCD may be established over one ormore networks, such as an encrypted 2.4 GHz Bluetooth low energy (BLE)connection. The hub/module and the PCD may initially pair using BLE 4.2LE secure connections feature, which includes Federal InformationProcessing Standards (FIPS)-approved Advanced Encryption Standard (AES)Cipherbased Message Authentication Code (CMAC), or AES-CMAS and P-256elliptic curve Diffie-Hellman (ECDH) algorithms on the BLE physicaltransport layer. The link between the hub/module and the PCD may beencrypted using security mode 4, link level encored security withencrypted key exchange, and secure simple pairing with short and longterm 128-bit keys. The particular pairing method used may vary asdesired. In some embodiments, numeric comparison, passkey entry orout-of-band (OOB) pairing methods may be used. The pairing willgenerally include exchanging of security initialization messages,creation of link keys and enabling encryption. Local keys may be storedin encrypted form in ferroelectric memory to increase the level ofsecurity.

The PCD provides a simple user interface to display global positioningsystem (GPS) data or other location data, health data, to receive localpush notifications relating to debugging (e.g., lost links, lowconfidence metrics, etc.), physiologic state warnings, etc. If thecommunication link is lost, health metrics, confidence metrics andtimestamps can be stored in local memory on hubs/modules until such timeas the link with the PCD can be reestablished. Link loss may be handledby a BLE link loss service (LLS). Data itself may be transmitted throughdifferent profiles, such as a BLE health device profile (HDP) and/or aBLE message access profile MAP). The HDP approach allows forcommunication of information directly to the PCD, which can allow forsending more information and for offloading computational burden to thePCD, and gives more robust data storage. The MAP approach allows thehub/module to directly take advantage of the messaging capability of thePCD to efficiently send health and confidence data in the form ofmessages through to a remote network or remote network server withoutoverly burdening the PCD (e.g., to conserve power or battery for a PCDimplemented using a mobile device such as a smartphone, smartwatch,wearable, etc.). In some embodiments, both HDP and MAP approaches areutilized.

FIG. 32 shows an example modular physiologic monitoring system,illustrating a structure for communicating to a remote server (shown asremote network 3206) through a PCD 3204 configured for communicationwith a sensing/stimulating device 3202 on subject 3201. Thesensing/stimulating device 3202 may be implemented as a patch/modulepair 3202.

FIG. 33 shows an example profile stack for communication between thepatch-module pair 3202 and the PCD 3204. In this embodiment, thepatch-module pair 3202 acts as the messaging client, while the PCD 3204acts as the messaging server. It is to be appreciated, however, that incertain communications the PCD 3204 may act as a messaging client whilethe patch-module pair 3202 acts as the messaging server. More generally,the profile stack shown in FIG. 33 may be used in a body area network(BAN) including multiple patch-module pairs and a host device such asPCD 3204. It is also to be appreciated that while a BLE profile stack isillustrated, various other protocols including other types ofshort-range wireless communication protocols may be used in otherembodiments. Each of the PCD 3204 and the remote server 3202 implementsa profile stack including a baseband, a link manager protocol (LMP), alogical link control and adaptation protocol (L2CAP), radio frequencycommunication (RFCOMM), service discovery protocol (SDP), an objectexchange (OBEX) client for message access service (MAS) and an OBEXserver for message notification service (MNS), bMessage parser andbMessage builder application objects used by message access profile(MAP) for message transport and an application.

While FIGS. 32 and 33 illustrate an example implementation with a singlepatch-module pair 3202, in other embodiments multiple patch-module pairsmay be used in a common BAN. Each patch-module pair may be configuredfor direct communication with the PCD 3204, such as using a BLE or otherBluetooth or short-range wireless communication protocol. In someembodiments, the patch-module pairs may also or alternatively beconfigured for communication with one another via a mesh network. Theremote link between the PCD 3204 and the remote server 3206 may utilizea different type of network more suitable for long-range communication.

While FIG. 33 shows an example of profile stacks built in accordancewith a Bluetooth protocol, communications between the PCD 3204 and theremote server 3202 may be over various types of wireless networks,including cellular networks, non-cellular networks such as satellitecommunication, etc. The selection of the type of wireless communicationused may be based, at least in part, on a tradeoff between battery lifeand ease of communication with optimal wearability in the field.

Modular physiologic monitoring systems described herein may be used in anumber of application areas, including with various types of end users.Examples of end users include but are not limited to incident responders(e.g., military officers, troops, police officers, fireman, dignitaries,physiotherapists, in military training, etc.). Modular physiologicmonitoring systems as described herein provide approaches forphysiological monitoring and/or management which is precise and userfriendly (e.g., comfortable, long-term wearable, etc.) and cost optimal.In some embodiments, metrics relating to autonomic activity derived fromprecise cardiac monitoring permit modular physiologic monitoring systemsto allow for new ways to quantitatively assess, monitor and treatsubjects in a wide variety of application areas including but notlimited to post-traumatic stress disorder (PTSD), depression, anxietydisorders, traumatic brain injury (TBI), situational awareness,training, medication management, etc.

Modular physiologic monitoring systems may be provide a number ofbenefits and advantages. In some embodiments, a robust design isprovided via patch-module pairs including hubs/modules that arewaterproof and sealed, with firm attachment and durable adhesion to apatch and via the patch to the subject, thus leading to user benefits inthat the patch-module pairs stay attached to the subject in extremecircumstances and environments. The patch-module pairs are also easy touse, in that the patch may be as easy to apply, remove and replace as astandard bandage, thus fitting into a subject's daily workflow withoutinterfering with daily routines. The patch-module pairs are alsocomfortable, in that they are lightweight and include highly stretchableand breathable membranes that are similar to skin and unobtrusive, andthus are suitable for long-term wear without the subject feeling thatthe patch-module pairs are being worn.

In some embodiments, modular physiologic monitoring systems providebenefits of robust data, in that patch-module pairs are configured formulti-modal data collection including via use of secondary sensors asdescribed above, thus providing increased confidence in data and moreaccurate assessments of user status. Physical attachment of patch-modulepairs may be hidden or visible, with the subtle physical profile ofpatch-module pairs allowing for strategic application to the subject forquality data and improved data confidence, which may reduce the risk offalse alarms and incorrect data.

Modular physiologic monitoring systems also provide benefits forlong-term measurements, such as continuous monitoring and feedback forchronic wear, providing hot-swappable hubs/modules, etc. thus fittinglong-term usage scenarios including military operations.

In some embodiments, cost of ownership benefits are provided, in thatthe modular physiologic monitoring system may utilize patch-module pairswith cost effective combinations of durable and disposable components,suitable for widespread usage including in military ruggedizedInternational Traffic in Arms Regulations (ITAR) stock-keeping unit(SKU).

Modular physiologic monitoring systems may also provide secure datathrough secure data transmission such as that conformable with Systemsand Network Attack Center (SNaC) and Department of Defense (DoD)security guidelines.

Data quality benefits may also be provided via reliable data collection,precise physiological data measurement and confidence metrics, thusallowing for high confidence in data accuracy even in extreme usagescenarios.

Versatile data and versatile software may also be provided in someembodiments. Patch-module pairs may be used for robust and redundantdata collection, providing fail-safes to continue collecting data duringfault or compromised usage scenarios. Versatile software providesproactive monitoring, user interfaces for event registration, on-goingcontinuous feedback, fallback storage during network downtime, etc. thusallowing for collection of data during down times, during useridentified alerts and events, etc.

It will be appreciated that additional advantages and modifications willreadily occur to those skilled in the art. Therefore, the disclosurespresented herein and broader aspects thereof are not limited to thespecific details and representative embodiments shown and describedherein. Accordingly, many modifications, equivalents, and improvementsmay be included without departing from the spirit or scope of thegeneral inventive concept as defined by the appended claims and theirequivalents.

What is claimed is:
 1. An apparatus comprising: a processor; and amemory coupled to the processor; the processor being configured: toreceive monitoring data from at least one sensing device coupled to asubject; to analyze the monitoring data to identify one or morephysiologic parameters of the subject; to provide signaling to at leastone stimulating device in response to the identified physiologicparameters, the signaling comprising instructions for controlling astimulus applied to the subject; wherein analyzing the monitoring datacomprises detecting one or more measured values of physiologicparameters indicating that an event is likely to occur; and wherein thestimulus is controlled to reduce a likelihood that the event will occur.2. The apparatus of claim 1, wherein the apparatus comprises a hostdevice wirelessly coupled to the sensing device and the stimulatingdevice.
 3. The apparatus of claim 1, wherein the signaling comprisesinstructions for controlling at least one of a type, a duration, and anamount of the stimulus applied to the subject to effect one or morechanges in the identified physiologic parameters.
 4. The apparatus ofclaim 1, wherein the stimulus comprises an electrical stimulus.
 5. Theapparatus of claim 4, wherein the electrical stimulus comprisesapplication of a pulse train.
 6. The apparatus of claim 5, wherein thepulse train comprises two or more pulses having duration and chargedelivery sufficient to stimulate tactile sensation while limiting painfiber stimulation.
 7. The apparatus of claim 5, wherein the signalingcomprises instructions for controlling at least one of: a duration of atleast one pulse in the pulse train; and a total charge of the at leastone pulse in the pulse train.
 8. The apparatus of claim 5, wherein thepulse train when applied to the subject mimics another stimulus, theother stimulus comprising at least one of vibration, pain, a wetsensation, heat or cold, taste, tension or stretch, sound, pressure andlight.
 9. The apparatus of claim 5, wherein the pulse train is appliedto the subject to amplify another stimulus, the other stimuluscomprising at least one of vibration, pain, a wet sensation, heat orcold, taste, tension or stretch, sound pressure and light.
 10. Theapparatus of claim 1, wherein the event comprises a sleep apneic event,and wherein the stimulus is applied to a plantar aspect of a foot of thesubject.
 11. The apparatus of claim 1, wherein the event comprisesdetermining a sleep posture of the subject, and wherein the stimulus iscontrolled to alter the sleep posture of the subject.
 12. The apparatusof claim 1, wherein the sensing device and the stimulating device arephysically distinct.
 13. The apparatus of claim 1, wherein the at leastone sensing device comprises a first sensing device at a first locationon the subject and a second sensing device at a second location on thesubject different than the first location.
 14. The apparatus of claim13, wherein the first sensing device is configured to measure a firstphysiologic parameter of the subject at the first location and thesecond sensing device is configured to measure a second physiologicparameter different than the first physiologic parameter at the secondlocation.
 15. The apparatus of claim 13, wherein the first sensingdevice and the second sensing device are configured to measure a samephysiologic parameter at the first location and the second location. 16.The apparatus of claim 1, wherein the at least one stimulating devicecomprises a first stimulating device at a first location on the subjectand a second stimulating device at a second location on the subjectdifferent than the first location.
 17. The apparatus of claim 16,wherein the signaling comprises instructions: to apply a first stimulusutilizing the first stimulating device at the first location; and toapply a second stimulus different than the first stimulus utilizing thesecond stimulating device at the second location.
 18. The apparatus ofclaim 1, wherein the at least one stimulating device is integrated intoa surface configured for contact with the subject.
 19. The apparatus ofclaim 1, wherein the at least one stimulating device is integrated intoa device not contacting the subject.
 20. The apparatus of claim 1,wherein the at least one stimulating device comprises: a disposablecomponent configured to conform to an anatomy of the subject andcomprising one or more electrodes configured to apply a stimulus to thesubject; and a reusable component configured to interface with thedisposable component, to receive the signaling, and to direct the one ormore electrodes to apply the stimulus in response to the signaling.